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1 |
A prospective, multicenter, randomized, double blind, parallel group study to compare the efficacy and safety of biosimilar cetuximab versus innovator cetuximab in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN) CLOSED |
PI- Dr. Hemant Malhotra
Co-PI- Dr. Ankur Punia & Dr. Ajay Yadav |
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2 |
A prospective, Multicenter, Randomized, Double Blind, Phase III study to compare the efficacy and safety of Biosimilar Bevacizumab of Enzene Bioscience Ltd. Versus Innovator Bevacizumab both in combination with CAPEOX in patients with Metastatic Colorectal Cancer. CLOSED |
PI - Dr. Hemant Malhotra
Co-PI- Dr. Ankur Punia & Dr. Ajay Yadav |
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3 |
A randomized, open lable, multicenter, two-treatment, two-period, two-sequence, two-way crossover, multiple dose, steady-state bioequivalence (BE) study of pazopanib HCI 200 mg tablets at a dose of 800 mg (4*200mg tablets) of lotus pharmaceutical CO., ltd.,Taiwan with VOTRIENT (pazopanib HCI 200 mg) tablets at a dose of 800 mg (4*200mg tablets) of novartis pharmaceuticals corporation, USA in subjects with advanced renal cell carcinoma under fasting condition. CLOSED |
PI- Dr. Prashant Kumbhaj
Co-PI- Dr. Ankur Punia & Dr. Ajay Yadav |
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4 |
A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION Breast01) CLOSED |
PI - Dr. Lalit Mohan Sharma
CO-PI - Dr. Priyanka Soni |
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5 |
A Phase III, Randomized, Open-label, with Tremelimumab + Lenvatinib Given Concurrently with Transarterial Chemoembolization (TACE) Compared to TACE Alone in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-3) |
PI- Dr. Hemant Malhotra
Co-PI- Dr. Lalit Mohan Sharma , Dr. Karan Kumar |
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6 |
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Single-Agent Chemotherapy in Patients who are not Candidates for PD 1/PD Li Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02) |
PI- Dr. Hemant Malhotra
CO-PI- Dr. Ankur Punia & Dr. Ajay Yadav |
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7 |
A Randomized, Multiple-dose, Multicentre, Comparative Parallel Study to Evaluate the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety of Subcutaneous Injection of Denosumab (Hetero) and Reference Medicinal Product (Denosumab, Amgen Inc.) in patients with bone metastases from solid tumours." CLOSED |
PI- Dr. Ankur Punia Co-PI- Dr. Hemant Malhotra |
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8 |
A Phase III, Randomised, Double blind, Placebo controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non-Small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8) |
PI- Dr. Lalit Mohan Sharma Co-PI- Dr. Priyanka Soni |
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9 |
A Phase 2, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial Comparing Chemoimmunotherapy (Paclitaxel-Carboplatin -Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) as Neoadjuvant Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma. |
PI - Dr. Hemant Malhotra
CO-PI - Dr. Ajay Yadav & Dr. Nitin |
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10 |
Phase 3, Open-Label, Randomized study comparing Gedatolisib in Combination with Palbociclib and
Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy. VIKTORIA-1 |
PI- Dr. Hemant Malhotra
CO PI- |
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11 |
Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (platelet counts <50,000/µL) |
PI- Dr. Naveen Gupta
CO PI- Dr. Priyanka Soni |
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12 |
A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor- Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
(CAPItello-292) |
PI- Dr. Prashant Kumbhaj
CO PI- Dr. Ankur Punia |
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13 |
Phase III, randomised study of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen
Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or
High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease. (Cambria-2) |
PI- Dr. Lalit Mohan Sharma
CO PI- Dr. Ajay Yadav |
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14 |
A Randomised, Double-blind, Placebo-Controlled, Phase III Study of AZD5305 in Combination with a Physician Choice of New Hormonal Agents in Participants with Metastatic Castration-Sensitive Prostate Cancer with and without HRRm (EvaPOR-Prostate01). |
PI- Dr. Prashant Kumbhaj
CO PI- Dr. Satyajeet Soni |
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15 |
Radical PC: RADICAL PC1 is a prospective cohort study of men with a new diagnosis of
prostate cancer
RADICAL PC2 is a randomized, controlled trial of a systematic approach to
modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of
prostate cancer |
Dr. Lalit Mohan Sharma |
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16 |
A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel study to
Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Biosimilar
Pertuzumab (ENZENE) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously
Untreated Patients with HER2 Positive Metastatic Breast Cancer. |
Dr. Hemant Malhotra |
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17 |
Cambria-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and
Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral
Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase
Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an
Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional
Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without
Disease Recurrence” |
Dr. Lalit Mohan Sharma |
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18 |
A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and
Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) as an Add-on
to Chemotherapy in Treatment-naïve Patients with Metastatic Non-squamous Non-small Cell Lung Cancer (LOTUS) |
Dr. Hemant Malhotra |
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19 |
A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig
(MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced
Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent
Chemoradiotherapy (eVOLVE-HNSCC) |
Dr. Lalit Mohan Sharma |