Completed Studies
Sr. No. | Year | Principal Investigator | Study Title | Phase | Protocol No. | Sponsor | CRO | Site | Study Status |
---|---|---|---|---|---|---|---|---|---|
1 | 2007 | Dr. M.S. Vishveshwara | A Randomized, Double- Blind, Multicenter Study of Denosumab compared with zoledronic acid (Zometa) in the treatment of Bone Metastasis in subjects with advanced Cancer (Excluding Breast and Prostate cancer) or Multiple Myeloma | III | 20050136 | Amgen | PPD | BHIO | Closed |
2 | 2007 | Dr. M.S. Vishveshwara | A Randomized, Double- Blind, Multicenter Study of Denosumab compared with zoledronic acid (Zometa) in the treatment of Bone Metastasis in subjects with Advanced Breast Cancer. | III | 20050244 | Amgen | PPD | BHIO | Closed |
3 | 2007 | Dr. Shekar Patil | A Phase 2, Multi-center, Open label, Randomized study of Mapatumumab (TRM-1 [HGS1012], a fully monoclonal antibody to TRAIL R1) in combination with Bortezomib (Velcade) and Bortezomib alone in subjects with relapsed or refractory Multiple Myeloma” | II | HGS1012-C1055 | HGS | Paraxel | BIO BHIO RGCI AIIMS |
Closed |
4 | 2007 | Dr. Shekar Patil | A Randomized, multicenter therapeutic confirmatory study to evaluate the efficacy and safety of Proxinium plus best supportive care Verses best supportive care alone in patients with advanced Squamous Cell Carcinoma of Head and Neck who have received at least one Anticancer treatment regimen for advanced disease | III | VB 4-845-01-IIIA | Viventia | Pharma-Olam | BIO | Closed |
5 | 2007 | Dr. Shekar Patil | A Randomized, DoubleBlind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer. | III | 20050103 | Amgen | PPD | BIO | Closed |
6 | 2007 | Dr. Shashidhara HP | A phase III randomized trial of chemotherapy with or without Panitumumab in patients with Metastatic and / or recurrent Squamous cell carcinoma of the head and neck | III | 20050251 | Amgen | PPD | BIO | Closed |
7 | 2007 | Dr. Bhawana Awasthy | Pilot Study: Differential Gene Expression Analysis of Selected Targets in Retrospective Human Pancreatic Ductal Adenocarcinoma | IIT | – | – | – | Triesta Sciences | Closed |
8 | 2007 | Dr. Niti Narang | A Phase ½ Modified Dose Escalation, Open Label Trial to determine the therapeutic Effect and Safety of INCB007839 combined with Trastuzumab in patients with previously untreated HER2 Positive Metastatic Breast Cancer | II | INCB7839-202 | Incyte | SIRO | BIO | Closed |
9 | 2008 | Dr. Niti Narang | An Open-label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory,CD22-Positive,Follicular B-cell Non-Hodgkin’s Lymphoma | III | 3129K4-3301-WW | Wyeth Pharmaceuticals | GVK Bio | BIO CMCC |
Closed |
10 | 2008 | Dr. Shekar Patil | A Phase III Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Cisplatin Chemotherapy | III | 017-00 | Merck | GVK Bio | BIO | Closed |
11 | 2008 | Dr. Shekar Patil | A Phase2 Safety and Efficacy Study of Bavituximab+Paclitaxel and Carboplatin in Patients with previously untreated locally Advanced or Metastatic Non-Small Cell Lung Cancer | II | PPHM – 0701 | Perigrene | Clinigene | BIO | Closed |
12 | 2008 | Dr. Ravi Diwakar | An Open Label Randomized Comparative Multicentric Study to Assess Safety and Efficacy of BIOMab – EGFR (Nimotuzumab) in Combination with Chemotherapy versus Chemotherapy alone in the Treatment of Patients with stage IIIB/IV Non Small Cell Lung Cancer (NSCLC). | III | CLG032/BIO013/NSCLC/h-R3/2008 | Clinigene | BIOCON | BIO | closed |
13 | 2008 | Dr. M.S. Vishveshwara | “An open label, muticenter phase 2 study to evaluate efficacy and safety of P276-00 in Indian subjects with recurrent, Metastatic or unresectable locally advanced squamous cell carcinoma of head and neck”. | II | P276-00/21/08 | Nicholas Piramal | Piramal Life Sciences | BHIO | Closed |
14 | 2008 | Dr. Ajai Kumar | “Evaluation of safety and efficacy of dendritic cell vaccine derived from autogenic blood aspirates in patients with stage II and III squamous cell carcinoma of head and neck.” | IIT | – | – | – | BIO | Closed |
15 | 2008 | Dr. Ajai Kumar | “Evaluationof the best feasible tissue (FFPE or snapFrozen tissue) for the detection of MGMT methylation status in patients with Gliblastoma multiforme | IIT | – | – | – | BIO | Closed |
16 | 2008 | Dr. Vineet Gupta | “An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients. ”. | II | CT 4002 | Medigene | Pharmanet | BIO | Closed |
17 | 2009 | Dr. Niti Narang | Multicentric Bioequivalence study comparing single dose of Capecitabine 500 mg tablets X 4 of Cipla Limited, (India) with single dose of Xeloda® 500 mg tablets X 4 (each containing 500 mg of Capecitabine) of Roche Ltd., U.K., in 72 patients with Colon, Colorectal or Breast Cancer under fed conditions. | BA/BE | PRC/CRD/33/08 | Cipla | Clintec | BIO | Closed |
18 | 2009 | Dr. Shekar Patil | Efficacy and Safetyof TULY (Rasburicase) in Prevention and Treatment of Malignancy – associated Hyperuricemia – an Open Label, Multicentre study in India | III | VB037-2007 | Virchow | Virchow | BIO | Closed |
19 | 2009 | Dr. Shekar Patil | Non Interventional Study of Indian Patients with Advanced Renal Cell Cancer receiving therapy with Sutent | IV | A6181181 | Pfizer | Pfizer | BIO | Closed |
20 | 2009 | Dr. Shekar Patil | Retrospective Data Collection Study for Breast Cancer | IIT | – | Institution | – | BIO | Closed |
21 | 2009 | Dr. Bhawana Awasthy | Study for assessment of Informed Consent Process | IIT | – | Institution | – | BIO | Closed |
22 | 2010 | Dr. Radheshyam Naik | Retrospective Evaluation of Efficacy and Safety of Generic Chemotherapeutic Formulations of Fresenius Kabi Oncology(Gemcitabine, Docetaxel, Irinotecan, Oxaliplatin and Paclitaxel) versus Historical Data in the Treatment of Advanced Colorectal Carcinoma (CRC), Non-small cell Lung Cancer (NSCLC), Carcinoma Breast, Squamous Cell Carcinoma of Head and Neck (SCCHN), Pancreatic Carcinoma and Gastric Adenocarcinoma in clinical practice setting in India: Retrospective, Comparative, Multicenter, Cohort study | IV | HNL/ONCO/01/10 | Fresenium kabi Oncology | Hanul Medizin | BIO | Closed |
23 | 2010 | Dr. Ashish Kaushal | a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-Care) | III | 20060359 (D-CARE) | Amgen | Amgen | Medisurge | Closed |
24 | 2010 | Dr. Shekar Patil | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer. | II | PPHM0902 | Perigrene | PRA International | BIO | Closed |
25 | 2010 | Dr. Radheshyam Naik | Efficacy and safety of Long-term (6 Months) Innohep® Treatment versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients/ IN 0901 INT. | III | IN 0901 INT | LEO Pharma | PRA International | BIO | Closed out |
26 | 2010 | Dr. Radheshyam Naik | Randomized, Comparative, Phase III Clinical Trial to Compare the Efficacy and Safety of Recombinant Human Pegylated Granulocyte Colony Stimulating Factor (Peg G-CSF) Versus Granulocyte Colony Stimulating Factor (G-CSF) In Subjects with Nonmyeloid Malignancies Receiving MyeloSuppressive Chemotherapy. | III | P3-Peg G-CSF-02 | Wockhardt | Wockhardt | BIO | Closed |
27 | 2010 | Dr. Shekar Patil | A phase 3, randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo In Women with Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or fallopian Tube Cancers | III | 20090508 | Amgen | NA | BIO | Closed |
28 | 2010 | Dr. Radheshyam Naik | An open-label multicentre phase IV study of trastuzumab in combination with the standard chemotherapy (as per the routine clinical practice) as first line therapy in patients with HER2 positive metastatic gastric cancer | IV | ML25477 | Roche | Roche | BIO | Closed out |
29 | 2010 | Dr. Shekar Patil | Establishment of registry for collating the epidemiology and treatment pattern data of Lymphoma in India | IIT | – | – | – | BIO | Closed |
30 | 2010 | Dr. Shekar Patil | A multicenter study of EGFR mutation analysis in non or ex-light smoker NSCLC Patients | IIT | – | – | – | BIO | Closed |
31 | 2010 | Dr. Ajai Kumar | A Prospective and Retrospective study to determine the Factors Affecting Disease Free Survival and Overall Survival in Patients with Gastric cancer Undergoing Curative Surgery | IIT | TS-04-2010 | HCG | Triesta | BIO | Closed |
32 | 2010 | Dr. Ajai Kumar | A project involving the systematic archival of snap frozen and/or formalin fixed paraffin embedded tissues from patients of malignancy undergoing surgery for their disease.//// A project involving the systemic archival of biospecimens (tissue, blood, plasma, serum, DNA samples) from patients of malignancy undergoing surgery/ biopsy for their disease | IIT | BR-008-02 | HCG | Triesta | BIO | Closed |
33 | 2010 | Dr. Shekar Patil | Open label, non controlled non randomized interventional pilot study to evaluate the response rate after induction therapy with Docetaxel and Cisplatin in unresectable locally advanced Squamous cell CA in head and Neck study | IV | DOCET_L_05090 | Sanofi Aventis | – | BIO | Closed |
34 | 2011 | Dr. Shekar Patil | Efficacy and safety of Paclitaxel nono-dispersion concentrate for injection (PICN) in subjects with metastatic breast cancer: A randomized, open label, active controlled, comparative, parallel group, and multi-centric study. | BA/BE | CLR_10_13 | SunPharma | Sun Pharma | BIO | Closed |
35 | 2011 | Dr. Shekar Patil | A Randomised, open-label, Phase 2 Trial of Paclitaxel/ Carboplatin with or without Bavituximab inpatients with Previously Untreated locally Advanced or Metastatic Non- Squamous Non-Small-Cell Lung Cancer. | II | PPHM1001 | Peregrine | PRA International | BIO | Closed |
36 | 2011 | Dr. Raghunath SK | An International, Multi-Center, Open Label, Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix versus Goserelin Depot (Zoladex®) in Men with Prostate Cancer | II | SPI-153-10-1 | Spectrum International | Oncorx | BIO | Closed |
37 | 2011 | Dr. Amit Verma | Ex-vivo study on Cervical Tissue characterization using Photonic Tool. | IIT | – | Philips | Triesta Referance Lab | BIO | Closed |
38 | 2011 | Dr. Ajai Kumar | A Randomized, multicenter, phase III open label study of the efficacy and safety of Trastuzumab-Mcc-Dml vs Capecitabine + Lapatinib in patients with Her 2 Positive locally advanced or Metastatic Breast Cancer who have received prior Trastuzumab – based therapy | III | BO21977 | Roche | Roche | BIO | Closed out |
39 | 2011 | Dr. Radheshyam Naik | Comparative PK, Efficacy, Safety and Immunogenicity evaluation of Bmab-200 versus Herceptin®, both in combination with Docetaxel in patients with Her2+ Metastatic Breast Cancer: A Double Blind, Randomised, Active control, Parallel assignment, Comparative Phase III, Clinical Trial | III | BM200-CT3-001-11 | Biocon | Clinigene | BIO | Closed |
40 | 2011 | Dr. Kumar Swamy | Clinical Validation of PROWESS IMRealART software for Adaptive Radiation therapy (ART) | IIT | TS-03-2011 | Siemens | Nil | BIO | Closed |
41 | 2011 | Dr. Radheshyam Naik | Development of preclinical screening platform for personalized breast cancer treatment in India | IIT | TS-04-2011 | Mitra Biotech | Nil | BIO | Closed |
42 | 2011 | Dr. Aditi Bhat | A Prospective Study to determine the Co-relation between Altered Biomarkers and poor response to Neoadjuvant Chemo radiation in Rectal Cancer | IIT | TS-02-2011 | HCG | HCG | BIO | Closed |
43 | 2011 | Dr. Shekar Patil | A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatiun, and a Fluoropyrimidine | III | I4T-MC-JVBB© (also known as IMCL CP12-0902) | Eli Lily | Eli Lilly | BIO | Closed out |
44 | 2011 | Dr. Radheshyam Naik | Collection of Serum Samples from Patients with Metastatic breast Cancer for Development and Validation of Bio-analytical methods for Bmab-200 | III | CL-BM200-001 | Biocon | Clinigene | BIO | Closed |
45 | 2011 | Dr. Sameer Khatri | An open label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting | II | 1200.98 (BI) | Manipal | Manipal | BIO | Closed |
46 | 2011 | Dr. Radheshyam Naik | A Randomised Open-label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 Monotherapy versus Paclitaxel in Patients with Advanced Gastric or Gastro-Oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (Shine Study) | IIA | D2610C00004 | Astrazeneca | Astrazeneca | BIO | Closed |
47 | 2012 | Dr. Shilpa Prabhu Desai | Digital Pathology Pilot study | IIT | – | Philips | – | BIO | Closed |
48 | 2012 | Dr. Amit Verma | Phase I/II Trial using Solid Lipid based Curcumin Nano-particles for early stage Bladder Cancer. | II | NA | ICMR | NA | BIO | Closed |
49 | 2012 | Dr. Shekar Patil | A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Docetaxel Injection Concentrate for Nano-dispersion (DICN) in Subjects With Unresectable Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) | IB | CLR_11_10 | Sun Pharma | Sun Pharma | BIO | Closed |
50 | 2012 | Dr. Sridhar P S | An International randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma. (The “ACT IV” Study) | IV | CDX110-04 | Celldex | Novatech | BIO | Closed |
51 | 2012 | Dr. Shekar Patil | Clinical and epidemiological Study of EGFR Mutation and EML4-ALK Fusion Gene Among Indian Patients with Adenocarcinoma Lung. | IIT | NA | Pfizer | Pfizer | BIO | Closed |
52 | 2012 | Dr. Shekar Patil | A Phase III Prospective, Two-Cohort, Non-Randomized, Multi-Centre, Multinational, Open Label Study To Assess The Safety Of Assisted And Self Administered Subcutaneous Trastuzumab As Adjuvant Therapy In Patients With Operable Her2 Positive Early Breast Cancer [SafeHer Study] | III | MO28048 | Roche | Roche | BIO | Closed |
53 | 2012 | Dr. Shekar Patil | A Multicenter open-label randomized study of BCD-020(rituximab, CJSC BIOCAD, Russia) efficacy and safety in comparison with MabThera® (F. Hoffmann-La Roche Ltd., Switzerland) in monotherapy of CD20-positive indolent non-Hodgkin lymphoma” | III | BIORIX | CJSC BIOCAD | SMO India | BIO | Closed |
54 | 2012 | Dr. Radheshyam Naik | An Exploratory, Obervational study to evaluate the Efficacy and Safety of Daptomycin in treating Neutropenic patients with fever due to known or suspected Gram Positive infections in adult Hemato-Oncology Patients. | IV | CCBC134AIN03T | Novartis | – | BIO | Closed |
55 | 2012 | Dr. KNC Murthy | Pharmacokinetics and Early Phase-II Clinical Study on anti inflammatory benefits of Dietary Triterpenoids | IIT | – | ICMR | NA | BIO | Closed |
56 | 2012 | Dr. Raghunath SK | A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA. | II | B1131004 | Pfizer | Parexel | BIO | Closed |
57 | 2012 | Dr. Raghavendra Rao | Prevalence and Perceptions of CAM in Indian Cancer Patients A Multi Institutional Cross Sectional Survey. | IIT | Academic Study | ICMR | Triesta | BIO | Closed |
58 | 2012 | Dr. Radheshyam Naik | A Phase III, Randomized, Double-Blind Active Comparator-Controlled Parallel-Group study Conducted Under In-House Blinding Conditions to examine the Efficacy and Safety of a Single 150mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of chemotherapy Induced Nausea and Vomiting (CINV) Associated with Moderately Emetogenic Chemotherapy | III | MK 0517-031 | Merck | Siro | BIO | Closed out |
59 | 2012 | Dr. Radheshyam Naik | A Randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation and non inferiority in analgesic efficacy in subjects with non-malignant or malignant pain that requires around-the-clock opioid therapy taking 50/25 – 80/40 mg twice daily as Oxycodone/Naloxone prolonged release (OXN PR) tablets compared to subjects taking 50 – 80 mg twice daily Oxycodone prolonged release (Oxy PR) tablets alone. | III | OXN3506 | Mundipharma | INC | BIO | Closed |
60 | 2012 | Dr. Sudhakar | Compare the lesion detection accuracy of Contrast Enhanced Spectral Mammography with Standard Mammography and Ultrasound in Women with Dense Breast or suspicious lesion. | IIT | TS-02-2012 | HCG/GE | Triesta | BIO | Closed |
61 | 2012 | Dr. K G Kallur | Benefits of PET VCAR2 in comparing baseline and follow-up PET/CT studies | IIT | TS-03-2012 | HCG/GE | Triesta | BIO | Closed |
62 | 2012 | Dr. Raghavendra Rao | Patterns of Care and Survival Studies | IIT | – | HCG/national Program | Triesta | BIO | Closed |
63 | 2012 | Dr. Radheshyam Naik | Retrospective Immunohistochemistry assessment of c-MET over expression in Head and Neck cancer in the Indian Population. | IIT | TS-04-2012 | GE Healthcare | Triesta | BIO | Closed |
64 | 2012 | Dr. Nalini Rao | Value of PET in staging and monitoring treatment response in breast cancer: A Retrospective analysis | IIT | – | GE Healthcare | Triesta | BIO | Closed |
65 | 2012 | Dr Shilpa Prabhu Desai | Magna Tech Technology | IIT | – | Biocon | – | BIO | Closed |
66 | 2012 | Dr. Shekar Patil | A Phase I/II First in Human, Open Label, Multi-centre, Dose Escalation, Dose Finding, Safety and Tolerability Study of BVX20 administered intravenously in patients with Relapsed/Refractory CD20+ B cell Non Hodgkin’s Lymphoma | I | BVX 20-CT-001-10 | Biocon | Clinigene | BIO | Closed out |
67 | 2012 | Dr. Radheshyam Naik | A multicenter, double-blind, randomized, parallel-group, phase III study to compare the efficacy and safety of Hercules versus Herceptin® in patients with HER2+ metastatic breast cancer | III | MYL-Her3001 | Mylan | INC | BIO | Closed |
68 | 2013 | Dr. Shekar Patil | A Phase III, open-label, multicenter, randomized trial to establish safety and efficacy of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive care. | III | BV-NSCLC-001 | Bioven | IndiPharma | BIO | Closed out |
69 | 2013 | Dr Pramod S Chinder | Efficacy of Autologous Mesenchymal stem cells transplantation and its correlation with tractography in patients with spinal cord diseases. | IIT | TS-01-2013 | HCG | HCG-BIO | HCG-BIO | Closed |
70 | 2013 | Dr. Radheshyam Naik | International multicenter randomized double blind phase III trial comparing safety and efficacy of BCD-021 (CJSC BIOCAD, Russia) and paclitaxel + carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and paclitaxel + carboplatin in inoperable or advanced non-squamous non-small-cell lung cancer patients. | III | BCD-021-02 | BIOCAD | BIOCAD | HCG-BIO | Closed |
71 | 2013 | Dr. Shekar Patil | A Phase III, multicenter, open-label, randomized trial comparing the efficacy of GA101 (RO5072759) in combination with chop (G-CHOP) versus Rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) | III | BO21005 | Roche | Roche | HCG-BIO | Closed |
72 | 2013 | Dr. Gopinath K.S. | An observational study to determine Thromboembolism prophylaxis in oncology patients who are undergoing abdominal or pelvic surgery | Observational Study | DIREGL06283 | Sanofi Aventis | Sanofi Aventis | HCG-BIO | Closed |
73 | 2013 | Dr. Radheshyam Naik | Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors. | II | CBEZ235Z2401 | Novartis | Novartis | HCG-BIO | Closed |
74 | 2013 | Dr Padma Kamineni | Correlation of Oncoprinting with K-RAS testing in Colorectal Cancer | Retrospective study | NA | HCG | HCG-BIO | HCG-BIO | Closed |
75 | 2013 | Dr. Radheshyam Naik | A Multicenter, Single Arm Study Of Trastuzumab Emtansine (T-Dm1) In Her2-Positive Locally Advanced Or Metastatic Breast Cancer Patients Who Have Received Prior Anti-Her2 And Chemotherapy-Based Treatment | III | MO28231 | Roche | Roche | HCG-BIO | Closed |
76 | 2013 | Dr.Govind Babu | A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-Squamous non-small cell lung cancer | III | CLDK378A2301 | Novartis | Novartis | HCG-CCO | Closed |
77 | 2013 | Dr. Radheshyam Naik | Post-marketing (Phase IV) Trial to monitor the adverse events of Fosaprepitant (EMEND® IV) in Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Moderate or High Emetogenic Chemotherapy in Usual Practice in India | IV | MK0517-035-01 | Merck | GVK Bio | HCG-BIO HCG-CCO | Closed |
78 | 2013 | Dr Rani Bhat | Comparative study to determine whether the Zetiq CellDetect® technology is as effective as the currently recommended approach Pap smear test for screening of cervical cancer | IIT | TS-0X-2013 | HCG | HCG-BIO | HCG-BIO | Closed |
79 | 2013 | Dr. Shekar Patil | Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib. | IV | OPTIMIS | Bayer Healthcare AG | Bayer Healthcare AG | HCG-BIO | Closed |
80 | 2014 | Dr. Raghunath SK | “A Multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinitor (Everolimus) 10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced Renal Cell Carcinoma patients under fasting condition”. | BA/BE | 13-VIN-537 | Par Pharmaceutical | Veeda CRO | HCG-BIO | Completed |
81 | 2014 | Dr. Raghunath SK | “Pharmacodynamics efficacy and safety of Leuprolide depot 7.5 mg (SPIL) in subjects with Prostate Adenocarcinoma”. | IV | CLR-13-14 | Sun Pharma | – | HCG-BIO | Closed |
82 | 2014 | Dr. Govinda Babu | “Aflibercept 4mg/kg intravenously every 2 weeks, in combination with irinotecan-fluoropyrimidine-based chemotherapy, in patients with metastatic Colorectal Cancer previously treated with an oxaliplatin-containing regimen”. | III | NA | Sanofi | – | HCG-SMH & HCG CCO | Closed |
83 | 2014 | Dr. K G Kallur | “Use of Radioisotopes for diagnositc and therapeutic purposes under proposal of Radioisotopes for diagnosis and therapy” | IIT | HCG BIO | – | HCG BIO | Closed | |
84 | 2014 | Dr. Shashidhara HP | A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokineticsand Immunogenecity between SB3(proposed transtuzumab biosimilar) and Herceptin in women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvent setting | III | SB3-G31-BC | SIRO | BIO | Closed | |
85 | 2014 | Dr. Radheshyam Naik | Incidence of invasive fungal infection in patients undergoing chemotherapy for acute myeloid leukemia – impact of antifungal prophylaxis. A prospective, multicenter, observational study in India | Observational Study | – | Merck | – | HCG Bio | Closed |
86 | 2014 | Dr. Sridhar P S | Interim PET/CT as a prognostic factor for Head/Neck Cancer | Retrospective study | – | – | – | – | Closed |
87 | 2014 | Dr. Basant Mahadevappa | To evaluate recurrence | Retrospective study | – | – | – | – | Closed |
88 | 2014 | Dr. K G Kallur | Requested for approval for PET images for feedback on Q –Clear processing software | IIT | – | WIPRO | GE Health care | – | Closed |
89 | 2014 | Dr. Vineet Gupta | Breast Cancer Registry to collate data on epidermiology and treatment patterns and outcomes of breast cancer in India | III | – | Roche | – | HCG-SMH | Closed |
90 | 2014 | Dr. K G Kallur | Benefits of PET VCAR2 in Comparing pre-treatment and Post treatment PETCT studies in Lymphoma Patients versus interpretation | IIT | TS-03-2012 | GE health care | – | HCG BIO | Closed |
91 | 2014 | Dr.Govind Babu | A Double Blind, Randomized, Active controlled, Parallel design, Comparitive PK, efficacy, Safety, and immunogenicity study of Bmab-100 and Avastin®, both in combimation with XELOX chemotherapy in patients with Metastatic Colorectal cancer. | III | BM100-CC-03-I-01 | Clinigene | – | HCG -CCO | Closed |
92 | 2014 | Dr.Govind Babu | A open label, Multi-centre, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity study number CLDK 378A2402 | III | CLDK378A2402 | Novartis | Novartis | HCG CCO | Closed |
93 | 2014 | Dr. Vishakha Mangale, | Comparative study and Identification of specific Hemato – Lymphoid abnormalities in peripheral blood or bone marrow or by multicolor flow cytometry | Retrospective study | – | Bangalore Development Centre, Beckman Coulter Inc | – | HCG BIO | Closed |
94 | 2015 | Dr. Shashidhara HP | A Multicentre, Open label, Balanced, Randomized, Two-treatment, Two-period, Single dose, Crossover, Bioequivalence study of Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients. | III | 14-VIN-648 | Dr. Reddy | Veeda | HCG BIO | Closed |
95 | 2015 | Dr. Shekar Patil | A Prospective, Comparative, Open Label, Randomized, Multicentric, Phase III study to compare the safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited against Avastin™ in Patients with Unresectable or Metastatic Non- Squamous Non-Small Cell Lung Cancer | III | 476-13 | Lambda | HCG BIO | Closed | |
96 | 2015 | Dr.Govind Babu | A Phase III randomized, double-blind, placebo controlled study of LEE011 or placebo in combination with tamoxifenand goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer | III | CLEE011E2301 | Novartis | HCG BIO | Closed | |
97 | 2015 | Dr. Radheshyam Naik | Reditux™ Registry to Compare Effectiveness, Safety and Resource Utilization of Reditux™ vs. the Reference Medicinal Product to Treat Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia in Routine Clinical Practice | Observational Study | RI-02-003 | Dr. Reddy | Pharmex | HCG BIO | Closed |
98 | 2015 | Dr. Raghunath SK | A Prospective, multicenter, post-marketing surveillance to assess safety of Zytiga® (Abiraterone Acetate Tablets 250 mg) in Indian patients with metastatic, castration-resistant prostate cancer as per locally approved prescribing information | IV | 212082PCR4021 | Janssen & Janssen | – | HCG BIO | Closed |
99 | 2015 | Dr.Govind Babu | A Phase Ib dose escalation followed by a phase II singlearmstudy of the combination of LEE011 with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2- negative, advanced breast cancer | IB | CLEE011A2115C | Novartis | HCG – BIO | HCG – CCO | Closed |
100 | 2015 | Dr. Radheshyam Naik | A Randomized, Double-Blind, Multi-Centre, Parallel Group Study Comparing Two Humanized Monoclonal Antibodies that Target HER2 Receptors in combination with Weekly Paclitaxel Administered as First-Line Treatment in Patients with HER2-Positive Metastatic Breast Cancer | III | TZ-01-002 | Dr. Reddy | Manipal Acunova | HCG – BIO | Closed |
101 | 2015 | Dr. Viveka B K | An Open Label, Single Arm Phase III Study of Nintedanib plus Best Supportive Care (BSC) in Patients with Colorectal Cancer Refractory to Standard Therapies | III | 1199.235 | Boehringer Ingelheim Pharmaceuticals, Inc | Boehringer Ingelheim Pharmaceuticals, Inc | HCG – BIO | Closed |
102 | 2015 | Dr. Radheshyam Naik | A Multicenter, Open-Label, Single-Arm, Phase IV Study Of Trastuzumab emtansine in Indian Patients with HER2 – Positive Unresectable Locally Advanced Or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and Taxane | IV | ML29662 | Roche | Roche | HCG – BIO | Closed |
103 | 2015 | Dr. Shekar Patil | A Phase III Randomized, Open – Label, Multi-Center, Global Study of MED14736 in combination with Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) (NEPTUNE) | III | D419AC00003 | Astrazeneca | Astrazeneca | HCG – BIO | Closed |
104 | 2015 | Dr. Raghunath SK | A Randomized, multicenter, open label, two- treatment, two period, two sequence, multiple dose, crossover , steady state bioequivalence study of Everolimus tablets, 10mg of Biocon limited, India vs Afinitor® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in advanced renal cell carcinoma (RCC) patients. | BA/BE | 15-VIN-155 | Biocon | Veeda | HCG – BIO | Closed |
105 | 2015 | Dr. Viveka B K | “A randomized double blind study in two parts Part A – Comparing two humanized monoclonal antibodies that target VEGF in combination with mFolfox 6 in patients with non-resectable metastatic colorectal cancer (mCRC) Part B – Comparing two humanized monoclonal antibodies that VEGF in combination with pemetrexed and carboplatin in recurrent or advanced non squamous non-small cell lung cancer (NSCLC)” | III | BZ-01-002 | Dr. Reddy | Diagnosearch | HCG – BIO | Closed |
106 | 2016 | Dr. Viveka B K | A study of Palbociclib in combination with Letrozole as treatment of post-menopausal women with hormone receptor-positive, Her 2 Negative advanced breast cancer for whom Letrozole therapy is deemed | III | A5481037 | Pfizer | Parexel | HCG – BIO | Closed |
107 | 2016 | Dr. Raghunath SK | An Open-label, Single-Arm, Multicentre, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed with Advanced Hormone-dependent Prostate Cancer | IV | 000201 / | Ferring | Maxneeman | HCG – BIO | Closed |
108 | 2016 | Dr. Shekar Patil | RIFTOS MKI – Radioactive Iodine reFractory asymptomatic patients in differentiated Thyroid cancer – an Observational Study to assess the use of MultiKinase Inhibitors | Observational Study | 17852 | Bayer Healthcare AG | Bayer Healthcare AG | HCG – BIO | Closed |
109 | 2016 | Dr. Radheshyam Naik | A Prospective, Placebo Controlled Study on Caripill Tablet in Management of Chemotherapy induced Thrombocytopenia in solid tumors | IIT | TS-01-2016 | Micro Labs Limited | Triesta | HCG – BIO | Closed |
110 | 2016 | Dr. Kumar Swamy | Effects of therapies for comorbidities on cancer presentation | IIT | – | HCG | HCG – BIO | Closed | |
111 | 2016 | Dr. Radheshyam Naik | A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate Fro Nano-Dispersion (PICN) And Abraxane® In Subjects With Locally Recurrent Or Metastatic Breast Cancer. | BA/BE | CLR_15_12 | Sun Pharma | Sun Pharma | HCG – BIO | Closed |
112 | 2016 | Dr. Yogesh Shivkumar | Using Circulating Tumour DNA (CtDNA) as a liquid biopsy – A validation study | IIT | – | HCG | – | HCG – BIO | Closed |
113 | 2016 | Dr. Radheshyam Naik | CORRELATE – Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings. | Observational Study | 16821 | Bayer Healthcare AG | Bayer Healthcare AG | HCG – BIO | Closed |
114 | 2016 | Dr.Govind Babu | A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/permetrexed in adult patients with EGFR mutated, cMET amplified, locally advanced/metastatic non-cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI). | II | CINC280B2201 | Biocad | – | HCG – BIO | Closed |
115 | 2016 | Dr. Shashidhara HP | A multi-centric, prospective observational registry of Everolimus across 2 indications and doses. | IIT | – | – | – | HCG – BIO | Closed |
116 | 2016 | Dr. Radheshyam Naik | A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study Of Paclitaxel Injection Concentrate For Nano-Dispersion (PICN) And Abraxane® In Subjects With Locally Recurrent Or Metastatic Breast Cancer | BA/BE | CLR_16_12 | Sun Pharma | – | HCG – BIO | Closed |
117 | 2016 | Dr. Radheshyam Naik | A Prospective, Multi Centre, Observational, Data Collection Registry Study To Monitor The Routine Clinical Use Of Mabtas (Rituximab 100 Mg / 500 Mg Concentrate For Solution For Infusion, Manufactured By Intas Pharmaceuticals Ltd) In Indian Patients. | Observational Study | 762-15 | Intas Pharmaceuticals | – | HCG – BIO | Closed |
118 | 2016 | Dr. Radheshyam Naik | A multicenter, Observational, Post Marketing Surveillance to Evaluate the Safety of Trastuzumab infusion (marketed as CANMAB of Biocon Limited, India/Hertraz TM of Mylan Pharmaceuticals Pvt. Ltd., India) administered as per the approved prescribing information in patients with HER2 overexpressing Metastatic Breast Cancer. | Observational Study | BIINTR001 | Cliantha Research Ltd | Cliantha Research Ltd | HCG – BIO | Closed |
119 | 2016 | Dr. Srinivasa B J | A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients | III | D419LC00001 | Astra Zeneca | Astrazeneca | HCG – BIO | Closed |
120 | 2016 | Dr.Govind Babu | A Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Study to Compare NSAI(Anastrozole or Letrozole) plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or plus Placebo and compare Fulvestrant plus Abemaciclib or plus Placebo in Postmenopausal Womwn with Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Brest Cancer. | III | 13Y-CR-JPBQ | – | Eil Lilly | HCG – BIO | Closed |
121 | 2016 | Dr. Radheshyam Naik | A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study Of Paclitaxel Injection Concentrate For Nano-Dispersion (PICN) And Abraxane® In Subjects With Locally Recurrent Or Metastatic Breast Cancer | BA/BE | CLR_16_13 | Sun Pharma | Sun Pharma | HCG – BIO | Closed |
122 | 2016 | Dr. Satheesh C T | A Phase 3, Randomized, Double-blind study of PF-05280586 Versus Rituximab for the First-line Treatment of Patients with CD20-Positive, Low Tumor Burden, Follicular Lymphoma | III | B3281006 | Pfizer | HCG | Closed | |
123 | 2016 | Dr. Shekar Patil | An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy | IV | 1199.272 | Boehringer-Ingelheim | HCG | Closed | |
124 | 2016 | Dr. Shekar Patil | A real-world, open-label, multi-center, prospective, non-interventional (observational) study to evaluate the effectiveness and tolerability of ceritinib in Indian patients with ALK positive metastatic non-small cell lung cancer who have progressed or are intolerant to crizotinib | IV | CLDK378AIN01 | Novartis healthcare | HCG | Closed | |
125 | 2016 | Dr.Govind Babu | A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) | III | CLDK378A2112 | Novartis | curie – a unit of HealthCare Global Enterprises Limited | Closed | |
126 | 2016 | Dr. Shekar Patil | A Multicenter, Observational, Post Marketing Surveillance to evaluate the Safety of Trastuzumab intravenous infusion (marketed as CANMAb of Biocon Limited, India/HertrazTM of Mylan Pharmaceuticals Pvt. Ltd., India) administered as per the approved prescribing information in patients with HER2 overexpressing Metastatic Breast Cancer | III | BIINTR001 | Novartis | HCG | Closed | |
127 | 2016 | Dr. Renu Ethirajan | Protocol for clinical validation of ShonitTM at HCG, Bangalore | Observational Study | sigtuple | HCG | Closed | ||
128 | 2016 | Dr. Radheshyam Naik | A prospective, multicenter, double-randomized, double-blind, 2-parallel groups, phase 3 study to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Folfiri 3 versus placebo in combination with Folfiri 3 in the treatment of patients with non resectable locally advanced or metastatic pancreatic cancer | III | AB12005 | AB Science | HCG | Closed | |
129 | 2016 | Dr. Sampathkumar MN | A Randomized, Double-blind, Multicentric, Parallel-group Study Comparing Efficacy, Safety and Immunogenicity of CBT124, a Candidate Biosimilar Bevacizumab in Combination with Carboplatin and Paclitaxel with EU-sourced Avastin® in Combination with Carboplatin and Paclitaxel in First-line Treatment for Subjects with Stage IV (Unresectable Recurrent Disease or Metastatic) Non-squamous Non-Small Cell Lung Cancer (NSCLC) | III | CBT124/CT/002 | cipla | HCG | Closed | |
130 | 2016 | Dr. Girish V Badarke | A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy and Safety of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma | III | AGB002 | Quintiles | HCG | Closed | |
131 | 2016 | Dr. Radheshyam Naik | A multicenter, open label, randomized, two treatment, two period, two way crossover, single dose, bioequivalence study of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension( (albumin-bound) 100 mg/vial by Celgene Corporation, USA in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. | BA/BE | CRD-09 | Siro ClinPharma | HCG | Closed | |
132 | 2016 | Dr. K G Kallur | Radioimmunotherapy with alpha particles Actinium 225 and Bismuth213 in HCG specialty center Bangalore | IIT | – | HCG – BIO | Closed | ||
133 | 2016 | Dr. Vijay Agarwal | A Randomized, Double-blind, Placebo-controlled, cross-over pilot study with Resveratrol in patients with advanced cancers undergoing non biological second line chemotherapy. | IIT | – | Epigenres Pvt Limited | HCG – BIO | Closed | |
134 | 2016 | Dr. Shashidhara HP | A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion of Trastuzumab (Hetero) and Reference Medicinal Product (HERCEPTIN® – Trastuzumab, Genentech, Inc.) in combination with standard chemotherapy in Patients of HER2-positive Metastatic breast cancer (TRUMAB Study). | III | HCR/III/TRUMAB/05/2016 | Hetero Drugs Limited | HCG – BIO | Closed | |
135 | 2017 | Dr. Shekar Patil | Safety Study of Nivolumab for Selected Advanced Malignancies in India. | IV | CA209-887 | ICON | HCG – BIO | Closed | |
136 | 2017 | Dr. Radheshyam Naik | PAzopanib Real-world Assessment of Clinical effectiveness and safety in patients wHo have Undergone Treatment in different sEttings in advanced renal cell carcinoma; a prospective, non-interventional, observational study. | IV | CPZP034AIC04 (PARACHUTE) | Novartis Healthcare Pvt Ltd | HCG – BIO | Closed | |
137 | 2017 | Dr. Shekar Patil | PAzopanib Real-world Assessment of Clinical effectiveness and safety in patients wHo have Undergone Treatment in different sEttings in advanced renal cell carcinoma; a prospective, non-interventional, observational study. | IV | CPZP034AIC04 (PARACHUTE) | Novartis Healthcare Pvt Ltd | HCG – BIO | Closed | |
138 | 2017 | Dr. Radheshyam Naik | A two arm, randomized, multicentric, open label, efficacy and safety study of Docetaxel Lipid Suspension (DLS) for Injection of Intas Pharmaceuticals Limited, India in Non-Small Cell Lung Cancer patients. | III | 0907-16 | Intas | Lambda Therapeutic Research Ltd | HCG – BIO | Closed |
139 | 2017 | Dr. Radheshyam Naik | A multicenter, open label, randomized, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer or metastatic breast cancer subjects under fed condition. | BA/BE | 0076-17 | Dr. Reddy’s Laboratories | Lambda Therapeutic Research Ltd | HCG – BIO | Closed |
140 | 2017 | Dr. Radheshyam Naik | An open label, balanced, randomized, two-treatment, two-sequence, two-period, crossover, multi center, multiple dose steady state bioequivalence study of Everolimus tablets 10 mg of Dr. Reddy’s Laboratories Limited, India comparing with that of AFINITOR® (everolimus) tablets 10 mg, Manufactured by Novartis Pharma Stein AG Stein, Switzerland in subjects of advanced renal cell carcinoma (RCC) who are already receiving Everolimus at a stable dose of 10 mg once a day as their individual therapy | III | 17-VIN-0028 | Dr. Reddy’s Laboratories | VeedaCR | HCG | Closed |
141 | 2017 | Dr Suraj H.P | NIS (Sodium Iodide Symporter) gene: Analysis of expression in Thyroid cancer patients – A pilot study | IIT | – | – | – | HCG | Closed |
142 | 2017 | Dr. Richitha V. Pandit | Actionable Genomic Mutations in Head and Neck Cancers: a pilot study | IIT | – | – | – | HCG | Closed |
143 | 2017 | Dr. Radheshyam Naik | Prospective Observational Study to Evaluate the Effectiveness of Syndrome Evaluation System in Diagnosis and Management of Infections in Bone Marrow Transplant and Malignant or Non Malignant Hematological Conditions | IIT | – | – | – | HCG | Closed |
144 | 2017 | Dr. Vishal Rao | Does palmistry/ vedic astrology have a role in time of the diagnosis of cancer patients – a cross sectional study | IIT | – | – | – | HCG | Closed |
145 | 2017 | Dr. Girish V Badarke | Comparative study and Identification of specific Hemato ‐ Lymphoid abnormalities and rare events in peripheral blood or bone marrow by multicolor flow cytometry | Observational Study | – | Beckman Coulter | – | HCG | Closed |
146 | 2017 | Dr. Gopinath K.S. | CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS-1): A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscript™ in Routine Clinical Practice | IIT | – | Mitra biotech | Catalyst Clinical Services | HCG | Closed |
147 | 2017 | Dr. Suraj HP | Evaluation of post-operative outcome of surgically treated patients with spine metastasis | IIT | – | – | – | HCG | Closed |
148 | 2017 | Dr. Suraj HP | Outcome of Bone Allograft reconstruction following Musculoskeletal tumour resections | IIT | – | – | – | HCG | Closed |
149 | 2017 | Dr. Shekar Patil | An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease – COMPLEEMENT-1 | IIIB | CLEE011A2404 | Novartis | Novartis | HCG | Closed |
150 | 2017 | Dr. Sudhakar | Multicentric Study to evaluate the effectiveness of Thermalytix© (automated thermographic screening algorithms developed by NIRAMAI) as compared to standard screening modalities in subjects who show possible symptoms of suspected breast cancer. | Observational Study | NI-THERMA-01 | NIRAMAI | NIRAMAI | HCG | Closed |
151 | 2017 | Dr. Satheesh C T | International multicenter randomized double-blind phase III trial comparing safety and efficacy of BCD-021 (CJS BIOCAD, Russia) and paclitaxel + carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and paclitaxel + carboplatin in inoperable or advanced non-squamous non-small-cell lung cancer patients. | III | BCD-021-02 | Biocad | Biocad | HCG | Closed |
152 | 2017 | Dr. Vishal Rao | Multi-centric Study for Screening and detection of oral potentially malignant disorders (OPMD) non-invasively by fluorescence and diffuse reflectance imaging with OralScan camera, and development of an algorithm for tissue discrimination. | IIT | – | Sascan Meditech | – | HCG | Closed |
153 | 2017 | Dr. Srinivasa B J | A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer. | II/III | DIV-SCLC-301 | United Therapeutics Corporation | Precision Oncology | HCG | Closed |
154 | 2017 | Dr. Radheshyam Naik | A Phase 2, Open-Label Randomized Trial Evaluating the Efficacy and Safety of Two Dosages of Once Daily Oral CA-170 in Patients with Selected Relapsed Advanced Tumors (ASIAD) | II | CA-170-201 | Aurigene Discovery Technologies Ltd. | Aurigene Discovery Technologies Ltd. | HCG | Closed |
155 | 2017 | Dr. Shekar Patil | A Phase II/III Pivotal, Open-label, Randomized, 3 Arm Study to Assess the Efficacy of LNP3794 Monotherapy or in Combination with Docetaxel, Compared with Docetaxel Alone, in Patients with RAS Mutation Positive Locally Advanced and Metastatic Non-Small Cell Lung Cancer. | II/III | LRP/LNP3794/2016/006 | Lupin | Lupin | HCG | Closed |
156 | 2017 | Dr. Srinivasa B J | Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. | Observational Study | RET-BIO-NIM-001 | ClinSync Clinical Research Pvt Ltd. | ClinSync Clinical Research Pvt Ltd. | HCG | Closed |
157 | 2017 | Dr. Shekar Patil | Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. | Observational Study | RET-BIO-NIM-001 | ClinSync Clinical Research Pvt Ltd. | ClinSync Clinical Research Pvt Ltd. | HCG | Closed |
158 | 2017 | Dr. Radheshyam Naik | Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. | Observational Study | RET-BIO-NIM-001 | ClinSync Clinical Research Pvt Ltd. | ClinSync Clinical Research Pvt Ltd. | HCG | Closed |
159 | 2017 | Dr. P.S. Sridhar | Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. | Observational Study | RET-BIO-NIM-001 | ClinSync Clinical Research Pvt Ltd. | ClinSync Clinical Research Pvt Ltd. | HCG | Closed |
160 | 2017 | Dr. Satheesh C T | Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. | Observational Study | RET-BIO-NIM-001 | ClinSync Clinical Research Pvt Ltd. | ClinSync Clinical Research Pvt Ltd. | HCG | Closed |
161 | 2017 | Dr. Shashidhara HP | Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. | Observational Study | RET-BIO-NIM-001 | ClinSync Clinical Research Pvt Ltd. | ClinSync Clinical Research Pvt Ltd. | HCG | Closed |
162 | 2017 | Dr. Satheesh C T | A randomised, controlled, comparative, open-label, multicenter study on the safety and efficacy of PEG Neutrogen and Neulastim in prevention of chemotherapy-induced neutropenia | Observational Study | VB066P/2017-CT4 | HCG KR | Closed | ||
163 | 2017 | Dr. Vijay Agarwal | A randomised, controlled, comparative, open-label, multicenter study on the safety and efficacy of Neutrogen and Neulastim in prevention of chemotherapy-induced neutropenia | Observational Study | VB066/2017-CT3 | HCG KR | Closed | ||
164 | 2017 | Dr. Shashidhara HP | A MULTICENTRE, OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF BORTEZOMIB FOR INJECTION 3.5 MG/VIAL OF DR. REDDY’S LABORATORIES LIMITED, INDIA AND VELCADE® (BORTEZOMIB) FOR INJECTION 3.5 MG/VIAL (DISTRIBUTED AND MARKETED BY: MILLENNIUM PHARMACEUTICALS, INC., 40 LANDSDOWNE STREET, CAMBRIDGE, MA 02139) IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA AND/OR RELAPSED MULTIPLE MYELOMA PATIENTS | III | 17-VIN-0772 | HCG | Closed | ||
165 | 2018 | Dr. Satheesh C T | A PHASE IV MULTI-CENTRIC POST-MARKETING STUDY EVALUATING THE SAFETY, IMMUNOGENICITY AND EFFICACY OF THE MARKETED FORMULATION OF HETERO – RITUXIMAB | IV | HCR/IV/Ritux/01/2017 | Hetero Drugs Limited | HCG KR | Closed | |
166 | 2018 | Dr. Satheesh C T | “A PHASE IV POST-MARKETING STUDY EVALUATING THE SAFETY, IMMUNOGENICITY AND EFFICACY OF THE MARKETED FORMULATION OF HETERO – BEVACIZUMAB IN SOLID MALIGNANCIES | IV | HCR/IV/Bevaci/01/2017 | Hetero Drugs Limited | HCG KR | Closed | |
167 | 2018 | Dr. Vijay Agarwal | a single arm, multicentric, open label, efficacy and safety study of docetaxel lipid suspension for injection of intas pharmaceuticals limited, india in metastatic gastric adenocarcinoma patients | III | 0328-17 | Lambda | HCG KR | Closed | |
168 | 2018 | Dr. Shekar Patil | “A Non-interventional, multicentre study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal and fallopian tube cancer patients in India (BRCA STUDY)”. | Observational Study | D0818R00001 | HCG KR | Closed | ||
169 | 2018 | Dr. Shekar Patil | “A phase IV study to investigate the safety and efficacy of regorafenib in Indian patients with metastatic colorectal cancer (mCRC)”. | Observational Study | 19214 | HCG KR | Closed | ||
170 | 2018 | Dr. Jaganath Dixit | “Prospective analysis of surplus fresh tumor tissue to understand the changes in tumor immune cells on exposure to immunomodulators using CANscript” | Observational Study | MBT-TB-038 | HCG KR | Closed | ||
171 | 2018 | Dr. Shekar Patil | “Clinical Outcomes of CLL and MCL patients treated with Ibrutinib : An Observational retrospective medical chart review from India”. | Observational Study | 54179060LYM4007 | HCG KR | Closed | ||
172 | 2018 | Dr.Govind Babu | A Phase III, multicenter, randomized, double blind, placebo-contorlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant theraphy in adult subjects with stages AJCC/UICC v.8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) | III | CACZ885T2301 | HCG DR | Closed | ||
173 | 2018 | Dr. Shashidhara HP | A multi-national randomized, multi-center, active controlled, open-label, Phase III study evaluating the efficacy of olmutinib versus platinum doublet chemotherapy in patients with T790M mutation positive locally advanced or metastatic non-smell cell lung cancer (NSCLC) whose disease progressed on one prior epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. | Observational Study | HM-EMSI-301 | HCG KR | Closed | ||
174 | 2018 | Dr. Shekar Patil | An observational, multicenter,prospective study to evaluate concordance of detecting EGFR mutation by circulating tumor free DNA versus tissue biopsy in NSCLC(CONCORDANCE) | Observational Study | D5161R00003 | HCG KR | Closed | ||
175 | 2018 | Dr. Shekar Patil | A multicenter, Prospective, Epideriolgical study to Evaluate the Incidence of Selected Mutation in Non-Small Lung (NSCLC) patients in India | IV | InSPIRE Registry | HCG | Closed | ||
176 | 2018 | Dr. Raghunath SK | “An exploratory pilot clinical validation study to correlate clinical outcome between physician decided therapy and its CANscriptTM response prediction in metastatic Catration Resistant Prostate Cancer (mCRPC)patients. | Observational Study | mCRPC study | HCG KR | Closed | ||
177 | 2018 | Dr. Shekar Patil | A Global, multicentre, three arms, open-label randomized study to evaluate the efficacy and safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere (Docetaxel Injection Concentrate) in triple – negative breast cancer patients with locally advanced or metastatic breast cancer after failure to prior chemotherapy. | III | 0063-17 | HCG KR | Closed | ||
178 | 2018 | Dr. Radheshyam Naik | “An Indian Multicentric Open Label Prospective Post Marketing Surveillance Study of Bevacizumab in The Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer In Real-Life Clinical Practice.” | IV | ML28446 | HCG KR | Closed | ||
179 | 2018 | Dr. Radheshyam Naik | “A retrospective study to assess the tumor response by correlating PET-CT with histopathology in Osteosarcoma patients at Tertiary Care Hospital.” | IIT | HCG KR | Closed | |||
180 | 2018 | Dr. Vishal Rao | “An observational, multicentre, prospective study to evaluate saliva based test in the early detection of Oral Cavity Squamous Cell Carcinoma (OCSCC).” | Observational Study | OCSCC | HCG KR | Closed | ||
181 | 2018 | Dr. Satheesh C T | A randomized, double-blinded, parallel group, Phase III trial to compare the efficacy, safety and immunogenecity of TX-05 with herceptin in subjects with HER2 positive early breast cancer | III | TX-05-03 | Tanvex | HCG | Closed | |
182 | 2018 | Dr. Satheesh C T | A doouble-blinded extension study to provide adjuvant treatment with single agent herceptin® or TX-05 and assessess continued safetty and immunogenecity in subjects with HER2 positive early breast cancer following neo-adjuvant treatment and surgical resection in protocol TX-05-03 | III | TX-05-04 | Tanvex | HCG KR | Closed | |
183 | 2018 | Dr. Radheshyam Naik | A multicenter, observational, registry to study the safety and efficacy bio similar trastuzumab intravenous infusion in patients with early breast cancer. | Observational Study | BM 200-EBC-04-1-2 | HCG KR | Closed | ||
184 | 2018 | Dr. Radheshyam Naik | An open-label, multicenter, randomized, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study of test product of Irinotecan Liposome Injection, 43 mg/vial (manufactured by: CSPC Ouyi Pharmaceutical Co., Ltd. Shijiazhuang Hebei China, for Actavis Inc.) with reference product ONIVYDE™ (Irinotecan Liposome Injection), 43 mg/ vial (manufactured for: Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ USA) in Combination with Fluorouracil and Leucovorin in Patients with Metastatic Adenocarcinoma of the Pancreas after Disease Progression Following Gemcitabine-based Therapy. | BA/BE | CT/IRI/1603 | HCG KR | Closed | ||
185 | 2018 | Dr. Radheshyam Naik | “A Multicenter Registry Examining The Clinical Utility Of Canscript In Routine Clinical Practice.” | Observational Study | MIT-201702 | HCG KR | Closed | ||
186 | 2018 | Dr. Shekar Patil | KINDLE “A multi-country, multi-centre, observational, retrospective study to reveal the patient characteristics, disease burden, treatment patterns and patient journey of stage III non-small-cell lung cancer patients | Observational Study | KINDLE | HCG KR | Closed | ||
187 | 2019 | Dr. Shekar Patil | A Phase III, Multicentre ,Randomised, Double-Blind,Placebo-Controlled Study Of Atezolizumab (ANTI-PD-L1 Antibody) In Combination with Paclitaxel Compared With Placebo With Paclitaxel For Patients With Previously Untreated Inoperable Locally Advanced Or Metastatic Triple Negative Breast Cancer.” | III | MO39196 | HCG KR | Closed | ||
188 | 2019 | Dr. Satheesh C T | A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma.” | III | RI-01-006 | HCG | Closed | ||
189 | 2019 | Dr. Satheesh C T | An open-label, randomized, Multiple Dose, Steady State, two treatments, three periods, three sequence, three way, Reference Replicated crossover bioequivalence study of 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil tablet in Metastatic colorectal cancer patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy, under fed conditions. | BA/BE | ARL/CT/18/004 | HCG | Closed | ||
190 | 2019 | Dr.Govind Babu | A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with hormone receptor positive/HER 2 negative inoperable locally advanced or metastatic breast cancer-CLEE011A3201C | II | CLEE011A3201C | HCG KR | Closed | ||
191 | 2019 | Dr. Satheesh C T | A Prospective, Randomized, Multicentre, Comparative, open-label, Parallel study to evaluate the Efficacy, Safety and Pharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3256; Cadila Healthcare Ltd) and Reference-Trastuzumab Emtansine (Kadcyla®, a product of Roche) in HER2- Positive Metastatic Breast Cancer Patients | III | TDM1.17.001.03 | HCG KR | Closed | ||
192 | 2019 | Dr. Satheesh C T | Randomized, Assessor-Blind, Multicentre, Parallel Group, Two Arms, Clinical Study to Assess the Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Test Product, Zydus) in comparison with Rituximab (Reference Product, Roche/Genentech) in Patients with Diffuse Large B Cell Lymphoma (DLBCL). | III | RITU.17.001.01.PROT | HCG KR | Closed | ||
193 | 2019 | Dr. Srinivasa B J | Tissue biopsy Replacement with unique Evaluation of circulating bio-markers for morphological evaluation and clinically relevant molecular typing of malignancies from Blood sample.” | Observational Study | HCG KR | Closed | |||
194 | 2019 | Dr. Srinivasa B J | “Circulating Tumor Cell (CTC) Assay as A Surrogate for Tissue Diagnosis of Suspected Breast Cancer.” | Observational Study | HCG KR | Closed | |||
195 | 2019 | Dr. Satheesh C T | “A Research on Currently Avaialble Method and Novel Technology of Micro RNA Quantification In Different Cancer Screenings | Observational Study | HCG KR | Closed | |||
196 | 2019 | Dr. Satheesh C T | “Collection of Blood Samples from Subjects with Lung Cancer or Acute Myeloid Leukemia for Immunophenotypic Characterization and Evaluation of Anti-tumor Activity of Peripheral Blood T cells. | Observational Study | SY-1901 | HCG KR | Closed | ||
197 | 2019 | Dr. Shekar Patil | A Long-term Follow -up study for Cardiac Safety in the patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC. | Observational Study | SB3-G31-BC-E | HCG KR | Closed | ||
198 | 2020 | Dr.Satheesh CT | “Efficacy and Tolerability of Sequencing Weekly Paclitaxel and Doxorubicin +Cyclophosphamide Regimen in HER-2 negative Breast Cancer.” | III | Closed | ||||
199 | 2020 | Dr. Satheesh C T | A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre, Study of CA-170 in Combination with Chemotherapy and Radiation in Patients with Unresectable Stage III or IVa Non-Squamous Non-Small Cell Lung Cancer (ASIAD-2).” | IIB/III | CA-170-301 | HCG KR | Closed | ||
200 | 2020 | Dr. Vishal Rao | An open label phase 1 clinical trial to evaluate safety and tolerability of Cytokine cocktail therapy in healthy volunteers from healthy donors (derived by T cells) | I | IMD/CoV/004/2020 | HCG KR | Closed | ||
201 | 2020 | Dr. Ajai Kumar | Phase I clinical trial to evaluate safety and efficacy of low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS, associated with COVID-19 infection” | I | TMT/COVID/002/2020 | HCG KR | Closed | ||
202 | 2020 | Dr. Shekar Patil | PIK3CA Registry – A descriptive study of PIK3CA mutations in patients with HR+/Her 2- advanced breast cancer | Observational Study | CBYL719C2401 | HCG KR | Closed | ||
203 | 2020 | Dr. Veena R | De-Identified Sample Acquisition Protocol for 100 Characterized Colorectal Carcinoma and Breast Cancer Tumor FFPE Blocks | Observational Study | ADX P#02 | HCG KR | Closed | ||
204 | 2020 | Dr. Satheesh C T | Collection of Blood Samples from Subjects of Breast, Lung and other Cancers for Liquid Biopsy Assay Validation of Peripheral Blood Mononuclear Cells | Observational Study | SLS-ERL-01 | HCG KR | Closed | ||
205 | 2020 | Dr. Sachin suresh Jadha | An Open label, Multi-Centre, Randomized, Two-treatment, Multi dose, Parallel, Comparative Bioavailability Study of Bortezomib Injection 3.5 mg/0.2 ml and VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2 in Multiple Myeloma patients.” | BA/BE | 727/18 | HCG KR | Closed | ||
206 | 2021 | Dr. Srinivasa B J | A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-way cross-over, multiple dose, steady-state Bioequivalence (BE) study of Pazopanib HCl 200mg Tablets at a dose of 800 mg (4 * 200 mg tablets) of Torrent Pharmaceuticals Ltd., India with VOTRIENT® (Pazopanib HCl 200mg) Tablets at a dose of 800 mg (4 * 200 mg tablets) of Novartis Pharmaceuticals Corporation, USA in subjects with Advanced renal cell carcinoma under fasting condition | BA/BE | CBCC/2020/002 | CBCC | CBCC | HCG KR | Closed |