A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Neoplasm
Trial Information
A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
The study included:
- A screening visit of up to 21 days prior to randomization
- Randomization at baseline
- A Treatment period (initiated within 3 days of randomization), which included 28-day
treatment cycles in both arms until predefined treatment discontinuation criteria were
met
- A follow-up visit 30 days after discontinuation of treatment,
- A post study treatment follow-up period until death or the study cutoff date.
The criteria for treatment discontinuation were:
- Participant (or legal representative) chose to withdraw from treatment
- The investigator thought that continuation of the study would be detrimental to the
participants well-being, such as:
- Disease progression
- Unacceptable AEs not manageable by symptomatic therapy, dose delay, or dose
modification
- Intercurrent illness that prevented further administration of study treatment
- Noncompliance with the study protocol
- Participant was lost to follow-up
- Unblinding of the participant's investigational treatment
Inclusion Criteria:
- Cytologically or histologically confirmed evidence of epithelial cancer
(adenocarcinoma) of the exocrine pancreas
- Metastatic disease
- No prior chemotherapy for pancreatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Adequate renal, liver and bone marrow functions
Exclusion Criteria:
- Less than 42 days elapsed from prior major surgery (28 days from other prior surgery)
to the time of randomization
- Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
- Uncontrolled hypertension
- Pregnancy or breastfeeding
- Participant with reproductive potential (M/F) without effective method of
contraception
The above information is not intended to contain all considerations relevant to potential
participation in a clinical trial.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Description:
OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009). OS time was estimated from Kaplan-Meier Plots.
Outcome Time Frame:
From the first randomization until the end of study data cutoff date (approximately 2 years)
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC10547
NCT ID:
NCT00574275
Start Date:
December 2007
Completion Date:
November 2010
Related Keywords:
- Pancreatic Neoplasm
- metastatic pancreatic cancer
- angiogenesis inhibitor
- gemcitabine
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |
