Selected Ongoing Studies

Selected Ongoing Studies
Clinical StudyPrincipal Investigator
Protocol No. TZ-02-001
Study Title: A Prospective, Single arm, Multicentre, Post-marketing Study (Phase IV) to evaluate safety and efficacy of Dr. Reddy’s Trastuzumab (DRL_TZ) in Patients with HER2- Positive Cancer. (Recruitment ongoing)
Dr. Murali Krishna Voonna
Protocol No. 0063-17 
Study Title: A global, multicenter, 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. (Recruitment ongoing)
Dr. Praveena Voonna
Protocol No. 0329-17
Study Title: A single arm, multicentric, open label, efficacy and safety study of Docetaxel Lipid Suspension for Injection of Intas Pharmaceuticals Limited, India in patients with Metastatic Castration Resistant prostate cancer.  (Recruitment ongoing)
Dr. Rakesh Reddy Boya
Protocol No. 0328-17
Study Title: A single arm, multicentric, open label, efficacy and safety study of Doceaqualip (Docetaxel Lipid Suspension for Injection of Intas Pharmaceuticals Limited, India) based regimens in metastatic gastric adenocarcinoma patients. (Recruitment Stopped)
Dr. Rakesh Reddy Boya
Protocol No. HCR/III/TREMBC/11/2016 
A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion of Trastuzumab Emtansine (Hetero) and Reference Medicinal Product (Trastuzumab Emtansine, Roche) in Patients of HER2-positive Metastatic breast cancer (TREMBC Study). (Recruitment ongoing)
Dr. Karthik Chandra Vallam
Protocol No. D9100C00001
Study Title: A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the efficacy and Safety of Durvalumab in Combination with and following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer (CALLA). (Recruitment Ongoing)
Dr. Rakesh Reddy Boya
Protocol No. D9106C00001
A Phase III, Double-blind, Placebo-controlled, Multi-centre International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-Small Cell Lung Cancer (AEGEAN). (Recruitment Ongoing)
Dr. Praveena Voonna
Protocol No. D933GC00001
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma. EMERALD (Recruitment Ongoing)
Dr. Rakesh Reddy Boya
Protocol No. 17-VIN-0772
A Multicentre, Open label, Balanced, Randomized, Two-treatment, Twoperiod, 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 (Recruitment Ongoing)
Dr. Rakesh Reddy Boya
Protocol No. 484-14
Safety and efficacy study of Azadine® (Azacitidine) in treatment of Myelodysplastic syndrome in Indian patients. (Recruitment Ongoing)
Dr. Chandrasekhar B