Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Protocol # 19-834

Status

Active, not recruiting

Description

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.

Condition

  • Grade 2 Glioma
  • Residual Glioma
  • Recurrent Glioma

Interventions

  • Vorasidenib
  • Matching Placebo

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Progression-Free Survival (PFS)

Secondary Outcome:

  • Time to Next Intervention
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Tumor Growth Rate as Assessed by Volume per the Blinded Independent Review Committee (BIRC)
  • Objective Response as Assessed per the BIRC and Investigator
  • Complete Response (CR) + Partial Response (PR) with Response Assessed per the BIRC and Investigator
  • Time to Response with Response Assessed per the BIRC and Investigator
  • Time to CR + PR with Response Assessed per the BIRC and Investigator
  • Duration of Response with Response Assessed per the BIRC and Investigator
  • Duration of CR + PR with Response Assessed per the BIRC and Investigator
  • Overall Survival
  • Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br)
  • Progression-Free Survival (PFS) as Assessed by the Investigator
  • Pharmacokinetics: Plasma Concentrations of Vorasidenib Collected at Specified Time Points
  • Pharmacokinetics: Plasma Concentrations of Metabolite, AGI-69460, Collected at Specified Time Points

Enrollment

340

Study Start Date

January 5, 2020

Eligibility

  • Gender:     All
  • Minimum age:     12 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Institut de Recherches Internationales Servier

Source

Servier

Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Clinicaltrials.gov Identifier

NCT04164901

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.