Clinical trial · Interventional
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Drug | Aflibercept | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo and Gemcitabine
- description
- Participants with metastatic pancreatic cancer administered Placebo and 1000 mg/m\^2 Gemcitabine.
- interventionNames
- Drug: Placebo
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Aflibercept and Gemcitabine
- description
- Participants with metastatic pancreatic cancer administered 4 mg/kg Aflibercept and 1000 mg/m\^2 Gemcitabine.
- interventionNames
- Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTRougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA. Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer. Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30. PMID 23642329