Safety, tolerability and efficacy of bevacizumab (Zydus Cadila) in nonsmallcell lung cancer (NSCLC)
- Conditions
- Malignant neoplasm of unspecifiedpart of bronchus or lung, non-squamous non-small celllung cancer,
- Registration Number
- CTRI/2015/08/006109
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
This is an A Prospective, Randomized, Multi-Center Study to Compare the Safety,Tolerability and Efficacy of Bevacizumab (Zydus Cadila) With Bevacizumab (Avastin®) in Non-Small Cell Lung Cancer (NSCLC) with Immunogenicity Assessment Extension study
The purpose of this study is to determine safety, tolerability, efficacy of bevacizumab (Test Product, Zydus) vs. bevacizumab (Reference Product, Roche/Genentech), in patients with unresectable, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 222
- Patient of both sex aged ≥ 18 years 2.
- Patient with history of histologically or cytologically confirmed non-squamous non-small cell lung cancer (defined as stage IIIB with malignant pleural effusion, stage IV, or recurrent disease) 3.
- Patients with advanced, unresectable or metastatic non-squamous NSCLC suitable for treatment with Bevacizumab, carboplatin and paclitaxel (BV and CP) therapy as a first line therapy 4.
- Bidimensionally measurable lesion according to RECIST 1.1 criteria 5.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 6.
- Patients able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial 8.
- Able to comply with study requirement in opinion of Principal Investigator.
- Pregnant and lactating women 2.
- Patient who have received prior chemotherapy or biotherapy, radiotherapy to an area measurable disease (unless disease progression is documented following completion of the therapy) or radiotherapy within past 2 weeks 3.
- History of clinically significant cardiac diseases (e.g., uncontrolled hypertension, myocardial infraction, unstable angina, NYHA ≥2 congestive heart failure, or serious cardiac arrhythmia) in past six months 4.
- History of serious or severe arterial thrombotic events and/or venous thromboembolic events (cerebral infarction, myocardial infarction, stroke, active symptomatic peripheral vascular disease; deep vein thrombosis, pulmonary embolism or proven coagulopathy in past three months.
- Recent or current use of aspirin or oral and/or parental anticoagulants (except low dose Coumadin 1 mg), known hypersensitivity to any components of the study medications and ingredients 6.
- History of surgery in past 4 weeks or planned elective surgery, fine needle biopsy, or an open biopsy within past one week 7.
- Any other medical conditions (including mental illness, substance abuse, social situations) deemed by the clinician 8.
- Patients with CNS metastasis 9.
- Gross hemoptysis (≥1/2 tsp red blood) or hematuria or hematemesis within 3 months 10.
- Absolute neutrophil count <1500/mm3 11.
- Platelets <100000/mm3 12.
- Creatinine level ≥1.5 mg/dL 13.
- Bilirubin level ≥1.5 × upper limit of normal (ULN) 14.
- Aspartate-aminotransferase(AST) and alanine-aminotransferase (ALT) levels ≥2.5 × ULN (≥5 × ULN for patients with liver metastases) 15.
- Alkaline phosphatase level ≥5 × ULN Cadila Healthcare Limited CLINICAL TRIAL PROTOCOL BEV.14.001.02.PROT CONFIDENTIAL PAGE 7 OF 80 Prepared by: Dr. Jayeshkumar Bhatt Approved by: Dr. R.
- Jani Protocol No. BEV.14.001.02.PROT Version No.: 2.0 16.
- Patient with non-healing wounds, ulcers or bone fractures 17.
- History of serious and / or severe infections such as Hepatitis C virus, hepatitis B virus, HIV infections, tuberculosis, etc.
- Simultaneous participation in other clinical trials, previous participation in other clinical trials within 3 months before entering into the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of best overall response rate (ORR) following bevacizumab (Test Product, Zydus) Time Point :-Day 127 and bevacizumab (Reference Product) treatment in patients with non-squamous non-small cell Time Point :-Day 127 lung cancer Time Point :-Day 127
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of bevacizumab following IV infusions of bevacizumab (Test Product, Zydus) and bevacizumab (Reference Product, Roche/Genentech) till Day 22 after cycle 6 with
Trial Locations
- Locations (27)
Acharya Tulsi Regional Cancer Treatment and Research Institute
🇮🇳Bikaner, RAJASTHAN, India
Apple Hospital
🇮🇳Surat, GUJARAT, India
Asian Cancer Research Institute
🇮🇳Jaipur, RAJASTHAN, India
BAPS Pramukhswami Hospital
🇮🇳Surat, GUJARAT, India
CIMS Hospital
🇮🇳Ahmadabad, GUJARAT, India
Curie Manavata Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
Department of Medical Oncology
🇮🇳Delhi, DELHI, India
Department of medical oncology AIMS
🇮🇳Delhi, DELHI, India
Department of Oncology
🇮🇳Ludhiana, PUNJAB, India
Department of Radiology King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Scroll for more (17 remaining)Acharya Tulsi Regional Cancer Treatment and Research Institute🇮🇳Bikaner, RAJASTHAN, IndiaDr Shankar Lal JakharPrincipal investigator9252385456drsjakhar@rediffmail.com