NCT00574275|TerminatedPhase 3ResultsDMC

Study Stopped

Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival

Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

VANILLA

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC10547EudraCT 2007-003476-19

Study Type

interventional

Target

546

Locations

24 countries

Sites

Timeline

RegisteredDec 2007

StartedDec 2007

CompletionNov 2010

Brief Summary

The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine. The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine). The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

546

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Dec 2007

Typical duration for phase_3

Geographic Reach

24 countries

24 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

December 1, 2007

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

September 25, 2012

Completed

Last Updated

June 7, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

December 14, 2007

Results QC Date

August 17, 2012

Last Update Submit

May 4, 2016

Conditions

Pancreatic Neoplasm

Keywords

metastatic pancreatic cancerangiogenesis inhibitorgemcitabine

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
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.
From the first randomization until the end of study data cutoff date (approximately 2 years)

Secondary Outcomes (5)

Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria
From the first randomization until the end of study data cutoff date (approximately 2 years)
Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria
From the first randomization until the end of the study data cutoff date (approximately 2 years)
Clinical Benefit
From the first randomization until the end of the study data cutoff date (approximately 2 years)
Safety-Number of Participants With Adverse Events (AE)
up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized.
Number of Participants With Anti-drug Antibodies
Up to 90 days post last dose of study drug

Study Arms (2)

Placebo and Gemcitabine

PLACEBO COMPARATOR

Participants with metastatic pancreatic cancer administered Placebo and 1000 mg/m\^2 Gemcitabine.

Drug: PlaceboDrug: Gemcitabine

Aflibercept and Gemcitabine

EXPERIMENTAL

Participants with metastatic pancreatic cancer administered 4 mg/kg Aflibercept and 1000 mg/m\^2 Gemcitabine.

Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)Drug: Gemcitabine

Interventions

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)DRUG

4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.

Aflibercept and Gemcitabine

PlaceboDRUG

4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle

Placebo and Gemcitabine

GemcitabineDRUG

1000 mg/m\^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.

Also known as: Gemzar

Aflibercept and GemcitabinePlacebo and Gemcitabine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.