Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
Phase 3
- Conditions
- Health Condition 1: C259- Malignant neoplasm of pancreas, unspecifiedHealth Condition 2: null- Pancreatic Neoplasm
- Registration Number
- CTRI/2008/091/000042
- Lead Sponsor
- SanofiSynthelabo India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 630
Inclusion Criteria
1.Cytologically or histologically confirmed evidence of epithelial cancer (adenocarninoma) of the exocrine pancreas
2.Metastatic disease
3.No prior chemotherapy for pancreatic disease
4.ECOG performance status (PS) 0, 1 or 2
5.Adequate renal, liver and bone marrow functions
Exclusion Criteria
"1. Less than 42 days elapsed from prior major surgery (28 days from other orior surgery) to the time of randomization
2. Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
3. Uncontrolled hypertension
4. Pregnancy or breastfeeding
5. Patient with reproductive potential (M/F) without effective method of contraception
"
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method