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Minor4 versionsRe-verified since Mar 12, 2026, no change to tracked fieldsv15-v18
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 55 to confirmed 51 · Study sites: 32 to 28v14Show 2 more changesShow less
Enrollment target: estimated 55 to confirmed 51
Study sites: 32 to 28
MinorEnrollment target: 42 to 55v13
MinorSite details revised at 2 of 32 sitesv12
MinorSite details revised at 3 of 32 sitesv11
Show 9 earlier versionsHide 9 earlier versions
MinorSite details revised at 2 of 32 sitesv10
MinorSite details revised at 3 of 32 sitesv9
MinorSite details revised at 19 of 32 sitesv8
MinorEnrollment target: 45 to 42Primary completion date: Jan 2028 to Nov 2027 · Completion date: Jan 2028 to Jun 2028v7Show 2 more changesShow less
Primary completion date: Jan 2028 to Nov 2027
Completion date: Jan 2028 to Jun 2028
MinorStart date: Jan 28, 2025 to Jan 22, 2025Site details revised at 2 of 32 sitesv6Show 1 more changeShow less
Site details revised at 2 of 32 sites
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Jan 16, 2025 to Jan 28, 2025 · Site details revised at 32 of 32 sitesv5Show 2 more changesShow less
Start date changed from estimate of Jan 16, 2025 to Jan 28, 2025
Site details revised at 32 of 32 sites
NotableStart date: Dec 2, 2024 to Jan 16, 2025v4
MinorStudy sites: 31 to 32v3
MinorStudy sites: 0 to 31v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.