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

Conditions

Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Brief summary

Radiographic PFS as assessed by the BIRC per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas [RANO-LGG]

Detailed description

1. The key secondary endpoint is TTNI., 2.Other secondary efficacy endpoints are TGR, objective response, CR+PR, time to response, time to CR+PR, duration of response, duration of CR+PR, OS, FACT-BR scores, and PFS by investigator., 3. Adverse events, serious adverse events (SAEs), and AEs leading to discontinuation or death, and severity of AEs, 4. Safety laboratory parameters, vital signs, 12-lead electrocardiograms (ECGs), evaluation of left ventricular ejection fraction (LVEF), Karnofsky Performance Scale (KPS)/Lansky Play-Performance Scale (LPPS), and concomitant medications., 5. Serial or sparse blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of vorasidenib and its circulating metabolite AGI-69460.

Related papers

No related papers found yet.

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGS95032/AG-881

DRUGPlacebo tablets to match S95032 drug product are supplied as white to off-white

DRUGround (10 mg) and white to off-white oblong (40 mg) film-coated tablets for oral administration.

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiographic PFS as assessed by the BIRC per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas [RANO-LGG]	—

Secondary

Measure	Time frame
1. The key secondary endpoint is TTNI., 2.Other secondary efficacy endpoints are TGR, objective response, CR+PR, time to response, time to CR+PR, duration of response, duration of CR+PR, OS, FACT-BR scores, and PFS by investigator., 3. Adverse events, serious adverse events (SAEs), and AEs leading to discontinuation or death, and severity of AEs, 4. Safety laboratory parameters, vital signs, 12-lead electrocardiograms (ECGs), evaluation of left ventricular ejection fraction (LVEF), Karnofsky Performance Scale (KPS)/Lansky Play-Performance Scale (LPPS), and concomitant medications., 5. Serial or sparse blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of vorasidenib and its circulating metabolite AGI-69460.	—

Measure

Time frame

1. The key secondary endpoint is TTNI., 2.Other secondary efficacy endpoints are TGR, objective response, CR+PR, time to response, time to CR+PR, duration of response, duration of CR+PR, OS, FACT-BR scores, and PFS by investigator., 3. Adverse events, serious adverse events (SAEs), and AEs leading to discontinuation or death, and severity of AEs, 4. Safety laboratory parameters, vital signs, 12-lead electrocardiograms (ECGs), evaluation of left ventricular ejection fraction (LVEF), Karnofsky Performance Scale (KPS)/Lansky Play-Performance Scale (LPPS), and concomitant medications., 5. Serial or sparse blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of vorasidenib and its circulating metabolite AGI-69460.

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Countries

France, Germany, Italy, Netherlands, Spain

Outcome results

None listed