Human Clinical Trials
Institute is continuously conducting human clinical trials. Recently institute has taken up Phase-III and Phase-IV trials as well. Several trials are multicentric and multinational. Institute is also conducting sponsored national and International Trails.
Recently Govt. Of India has designated institute as Regional clinical trial unit (RCTU) (MRU/MRHRU Network)
In this regards a committee has been constituted to prepare guidelines for establishing robust mechanism for hassle free conduction of trials with international standards.
| Sn. | Member Name | Designation in RAC |
|---|---|---|
| 1 | Dr. Shailandra Shankar Handu | Prof and HOD, Department of Pharmacology |
| 2 | Dr. Uttam Kumar Nath | Prof. and HOD, Department of Medical Oncology Haematology |
| 3 | Dr. Farhanul Huda | Additional Professor, Department of General Surgery |
| 4 | Dr. Puneet Dhamija | Additional Professor, Department of Pharmacology |
| 5 | Dr. Ashish R. Bhute | Member Secretary, IEC, AIIMS Rishikesh |
| 6 | Dr. Amit Sehrawat | Assistant Professor, Department of Medical Oncology Haematology |
| 7 | Mr. Rajiv Gupta | Account Officer |
List of PHASE- III and Phase IV trials
| S. No. | Title of project | Name of PI & designation Department | Funding Agency | Single center/multicentric multinational |
| 1. | An open label no inferiority Phase III Randomized, Controlled Trial of Weekly versus Three weekly Cisplatin & Radical Radiotherapy in locally advanced Head & Neck Squamous Cell Carcinoma | Name of PI: Dr Amit Sehrawat Designation: Assistant Professor Department: Medical oncology Hematology | SPONSOR: AIIMS New Delhi | Multicentric (India) (Phase III Trial) |
| 2. | A multicenter, open label, Randomized, study to evaluate the efficacy and safety of Paclitaxel Lipid suspension for Injection in Patients with recurrent Metastatic Ovarian Carcinoma | Name of PI: Dr Amit Sehrawat Designation: Assistant Professor Department: Medical oncology Hematology | SPONSOR: INTAS Pharmaceuticals limited CRO: Lambda Therapeutic Research Limited | Multicentric (Phase II Trial) |
| 3. | An open-labeled, randomized, comparative, multi centric, clinical study to evaluate the efficacy and safety of UPLAT ® in Patients suffering from chemotherapy induced thrombocytopenia (CIT). | Name of PI: Dr Puneet Dhamija Designation: Additional Professor Department: Pharmacology
Name of Co-I: Dr Amit Sehrawat Designation: Assistant Professor Department: Medical oncology Hematology | Sanat Products Ltd. a part of Dr. Willmar Schwabe India Pvt. Ltd. | Multicentric (Indian) (Phase IV Trial) |
| 4. | A prospective, single-arm, multicenter, study to assess safety and efficacy of ROMY® (Romiplostim Powder for Injection) (INTAS pharmaceuticals Ltd India) in patients with Chronic Refractory Immune System (Idiopathic) thrombocytopenic purpura (ITP)* | Name of PI: Dr Gaurav Dhingra Designation: Assistant Professor Department: Medical oncology Hematology
Name of Co-I: Dr Amit Sehrawat Designation: Assistant Professor Department: | SPONSOR: INTAS Pharmaceuticals limited CRO: Lambda Therapeutic Research Limited | Multicentric (Indian) (Phase IV Trial) |
| 5. | 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) * | Name of PI: Dr Amit Sehrawat Designation: Assistant Professor Department: Medical oncology Hematology | SPONSOR: AstraZeneca | Multicentric (Phase III Trial) |
| 6. | A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer * | Name of PI: Dr Amit Sehrawat Designation: Assistant Professor Department: Medical oncology Hematology | SPONSOR: AstraZeneca | Multicentric (Phase III Trial) |
*The study was submitted to IEC for their review & approval.