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

EC SOPs

EC Membership List