deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT00574275

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

Updated 13 times since 2017 Last updated: May 4, 2016 Started: Dec 31, 2007 Primary completion: Oct 31, 2009 Completion: Nov 30, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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This PHASE3 trial investigates Pancreatic Neoplasm and is currently terminated or withdrawn.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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~May 2018 · 9 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 6 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

13 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE3

  2. Oct 2025 — Present [monthly]

    Terminated PHASE3

  3. Sep 2025 — Oct 2025 [monthly]

    Terminated PHASE3

  4. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

Show 8 earlier versions
  1. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  2. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  3. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  4. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  5. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  6. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  7. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE3

  8. 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

Sponsor contact:
  • Regeneron Pharmaceuticals
  • Sanofi
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .