Past Trials
E7080-M091-511 Tittle
"A Prospective, Multicentre, Post-Marketing Phase IV Study to Assess the safety and Efficacy of Lenvatinib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HCC)".
Ref: E7080-M091-511
“A Prospective, Multicentre, Post-Marketing Phase IV Study to Assess the safety and Efficacy of Lenvatinib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HCC)”
Site: Somani Hospital, Principal Investigator - Dr. Naresh Somani
Ref: Protocol: 0063-17
A global, multicenter, three arms, open-label randomized study to evaluate the e?cacy 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.
Protocol Title :
‘A Prospective, Randomized, Multicentre, Comparative, open-label, Parallel study to evaluate the E?cacy, Safety and Pharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3255; Cadila Healthcare Ltd) and Reference-Trastuzumab Emtansine (Kadcyla@, a product of Roche) in HER2- Positive Metastatic Breast Cancer Patients.
Protocol Title:
A randomized, double-blind, placebo-controlled, phase III study evaluating the e?cacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as ?rst line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1).
Protocol Title:
"A pilot study (Phase II Trial )of Ge?tinib With Pemetrexed as First-Line Therapy in Patients With Advanced Non-squamous Non–Small-Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations positive patients." (Investigator Initiative Trial).
Protocol Number: WOC/AMS/CT-44/14
"A surveillance study on the antibiotic susceptibility pattern of bacterial isolates collected from patients at various Indian tertiary care hospitals"
Protocol No. CA209-887
Study Title: Clinical Outcomes of CLL and MCL patients treated with Ibrutinib : An observational retrospective medical chart review from India - (Recruitment Ongoing) - Dr. Naresh Somani
Safety Study of Nivolumab for Selected Advanced Malignancies in India - (Trial Ongoing Recruitment closed) - Dr. Naresh Somani
Reference: 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 - (Trial Ongoing Recruitment closed)
CLDK378A2301
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 (Phase-III)- Principal Investigator- Dr. Naresh Somani
Protocol No. WOC/AMS/CT-44/14
A Surveillance Study on the Antibiotic susceptibility pattern of bacterial isolates collected from patients at various Indian Tertiary Care Hospitals (ASPIRE INDIA)
Project # MYL-1402O-3001
Multicentre, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First -line treatment of Patient with Stage IV Non-Squamous Non-Small Cell Lung Cancer.
Protocol No: CLDK378AIN01
A real-world, open-label, multi-center, prospective, non-interventional (observational) study to evaluate the effectiveness and tolerability of ceritinib in Indian pativvents with ALK positive metastatic non-small cell lung cancer who have progressed or are intolerant to crizotinib.
Protocol Title: CPZP034AIC04 Parachute
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, observation study.
Protocol No. 20070337 Study
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women with Osteoporosis.
Protocol No. CBKM120H2201
Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib (BKM120) plus paclitaxel vs. Placebo plus paclitaxel in patients with platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma.
Protocol No. CLDK378A2301
A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), locally advanced or metastatic, non- squamous non-small cell lung cancer.
Protocol No. GP13-301
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus cyclophosphamide, vincristine, prednisone vs. MabThera® plus cyclophosphamide, vincristine, prednisone, Followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma.
Study to evaluate the efficacty of Erlotinib (Tarceva® ) following 4 cycles of platinum based chemotherapy in patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who have not experienced disease progression or unacceptable toxicity during Chemotherapy
A Study to assess the safety and efficacy of Cetuximab plus Radiotherapy (RT) in Locally Advanced Squamous Cell Carcinoma of Head & Neck (LA SCCHN)
Protocol No. 2-55-52030-730/TR321
A double-blind, randomized placebo- Controlled clinical trial investigating the efficacy and safety of Somatuline Depot (lanreotide) Injection in the treatment of carcinoid syndrome.
Protocol WSA-CS-008
A Phase III, Double Blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 versus a Caspofungin followed by Voriconazole Regimen in the Treatment of Candidemia and other Invasive Candida Infection.
Protocol BI1200.98
An open label, phase II trial of BIBW 2992 (Afatinib) in patients with metastatic HER-2 Over expressing breast cancer failing HER2-targeted treatment in the neoadjuvant or adjuvant treatment setting.
A Post-Marketing Surveillance Study to assess the safety and efficacy of Cetuximab plus Radiotherapy (RT) in Locally Advanced Squamous Cell Carcinoma of Head & Neck (LA SCCHN).
A Open-Label Single-Arm observational Study of Pemetrexed in Combination with Cisplatin in Patients with Advanced stage IIB/IV Non-Small Cell Lung Cancer Cancer to assess the PFS. (Progression Free Survival) in Indian context.
An Observational Study to evaluate the safety and efficacy of Erbitux in combination with platinumum based ch
PRESTIGE STUDY
An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX 10.8 mg Given Every 12 Weeks with ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer.
SERENITY STUDY
Study No. - P1446A: An open lable, Multicentre Phase II study of Selective Cyclin Dependent Kinase Inhibitor. In subjects with Advanced Refractory Malignancies.
Study No. - BIBF-1193.13
A multicentre, randomized, double blind, Phase 3 Trial to investigate the efficacy and safety of oral BIBF 1120 plus standard docetaxel therapy compared to placebo plus standard docetaxel therapy in patients with stage IIIB/IV orrecurrent non small cell lung cancer after failure of first line chemotherapy.
Bafetinib-P2-HRPC-01-A Phase II Study of Bafetinib (INNO-406) as Treatment for Patient with Hormone- Refractory Prostate Cancer.
Fighting cervical cancer, FOGSI cervical cancer registry, a reaching the unreached FOGSI initiative 2010. . A pap smear & HIV DNA & colposcopy based study.
Docet Study
A multicenter, double blind, randomized, fully replicate, crossover, comparative pharmacokinetic and safety study in female patients to show essential similarity of a novel formulation of intravenous Actavis Docetaxel (Docetaxel 20 mg/ml ) concentrate for solution for infusion to provide 100mg/m² Docetaxel and commercially available Taxotere® (Docetaxel 40 mg/mL), concentrate for solution for infusion to provide 100 mg/m² Docetaxel.
A phase II study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer patient receiving Treatment with Gemcitabine.
Safety and Efficacy of Recombinant Human Granulocyte-colony Stimulating Factor-rhGCSF (ReliGrastTM or Neupogen®) in Patients with Chemotherapy Induced Neutropenia (Protocol No : GMX-GCSF-CT001)
Study No. - PT-101
Phase 1 Study of Intravaginal Tamoxifen (PT-101): Randomized, double blind study of safety, pharmacokinetic (PK) and pharmacodynamics (PD) in menopausal patients with moderate to severe Vulvar and vaginal atrophy.
Study No. - DOCET_R_02271
This is a multi-country, multi-centre, single arm non-interventional, prospective registry study.
Active implementation of Quality of Life (QOL) assessment in clinical practice for patients with advanced NSCLC and comparison of QOL and response endpoints.
VANILLA STUDY
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Study Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer
Investigator Initiative Clinical Trial
- A pilot study (Phase II Trial) of Cetuximab with Afatinib as First-Line Therapy in patients With Advanced Non-Sequamous Non-Samall-Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Multations positive patients. - PI Dr. Naresh Somani
- A pilot study (Phase II Trial ) of Gefitinib/Afatinib with pemetrexed as First-Line therapy in Patients with advanced Non-squamous Non-Small-Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutations positive patients. PI Dr. Naresh Somani
- A pilot study (Phase II Trial ) of Nivolumab with Pemetrexed as Palliative Chemotherapy in Patients with advanced Non-Small-Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutations positive patients. PI Dr. Naresh Somani