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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasm

Thank you

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 OfficeBridgewater, New Jersey  08807