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
Sponsor: Regeneron Pharmaceuticals
Terminated
Data Monitoring Committee concluded after a planned interim analysis that aflibercept added to gemcitabine would be unable to demonstrate improved survival
This PHASE3 trial investigates Pancreatic Neoplasm and is currently terminated or withdrawn. Regeneron Pharmaceuticals leads this study, which shows 13 recorded versions since 2007 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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
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
Status Flow
Change History
13 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
-
Oct 2025 — Present [monthly]
Terminated PHASE3
-
Sep 2025 — Oct 2025 [monthly]
Terminated PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
▶ Show 8 earlier versions
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Dec 2021 — Jul 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Terminated PHASE3
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Nov 2020 — Jan 2021 [monthly]
Terminated PHASE3
-
Jun 2018 — Nov 2020 [monthly]
Terminated PHASE3
-
May 2018 — Jun 2018 [monthly]
Terminated PHASE3
-
Aug 2017 — May 2018 [monthly]
Terminated PHASE3
-
Feb 2017 — Aug 2017 [monthly]
Terminated PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Terminated PHASE3
First recorded
Dec 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Regeneron Pharmaceuticals
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Athens, Greece , Barcelona, Spain , Berlin, Germany , Bogotá, Colombia , Brastislava, Slovakia , Bridgewater, United States , Bucharest, Romania , Budapest, Hungary , Buenos Aires, Argentina , Diegem, Belgium and 14 more locations