Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified Health Condition 2: null- Pancreatic Neoplasm
Conditions
Interventions
Intervention1: Aflibercept (AVE0005 - VEGF Trap): Aflibercept 4 mg/kg over 1 hour I.V. every 2 weeks.
Control Intervention1: Gemcitabine: Gemcitabine 1000 mg/m2 IV administered over 30 minutes.
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
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
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 "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: From the first randomization until the end of study data cutoff date (approximately 2 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and, in selected centers the pharmacokinetics of aflibercept. Timepoint: From the first randomization until the end of study data cutoff date (approximately 2 years) | — |
Countries
Belgium, Canada, Germany, India
Contacts
Public ContactSalini James
Sanofi-Synthelabo (India) Limited
Outcome results
None listed