Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT06478212
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • IDH1-mutant Glioma
  • IDH2-mutant Glioma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    To be taken by mouth once daily in 28-day cycles with no break between cycles
  • Temozolomide (TMZ) — DRUG
    To be taken by mouth once daily for the first 5 days of each 28-day cycle, for a maximum of 12 cycles

Study Details

The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib. The study will begin as a Phase Ib study to determine the RCD and then will transition to a Phase II study to assess the clinical efficacy of vorasidenib at the RCD in combination with TMZ. During the treatment period participants will have study visits on day 1 and 22 of each cycle, with additional visits occurring during the first cycle of the Phase 1b study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur and then participants will be followed for survival every 3 months. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination.

Key Dates

Start date
Jan 22, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Vorasidenib and Temozolomide (TMZ)
  • Experimental: Phase 2: Vorasidenib recommended combination dose (RCD) and Temozolomide (TMZ)

Primary Outcome Measure

Phase 1b ONLY: Dose-limiting toxicities (DLTs) [ Time Frame: Through cycle 1 (each cycle is 28 days) ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
University of MiamiMiamiFlorida33136-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CAUniversity of Miami· Miami, FLDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYDuke University Medical Center· Durham, NCMD Anderson Cancer Center· Houston, TX

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