Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
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|ClinicalTrials.gov Identifier: NCT04164901|
Recruitment Status : Active, not recruiting
First Posted : November 15, 2019
Results First Posted : November 24, 2023
Last Update Posted : December 5, 2023
|Condition or disease||Intervention/treatment||Phase|
|Grade 2 Glioma Residual Glioma Recurrent Glioma||Drug: Vorasidenib Drug: Matching Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||331 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants randomized in a 1:1 allocation (vorasidenib vs Placebo)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 5, 2020|
|Actual Primary Completion Date :||September 6, 2022|
|Estimated Study Completion Date :||August 2027|
Vorasidenib 40 mg, continuous daily dosing.
Vorasidenib oral film-coated tablets
Other Name: AG-881
Placebo Comparator: Matching Placebo
Matching placebo 40 mg, continuous daily dosing.
Drug: Matching Placebo
Matching Placebo oral tablets
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 30 months ]PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier.
- Time to Next Intervention [ Time Frame: Up to approximately 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164901