Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma (NCT06478212) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma
United States51 participantsStarted 2025-01-22
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Absolute neutrophil count ≥1,500/mm3 or 1.5×109/L
✓. Hemoglobin ≥9 g/dL or 90 g/L
✓. Platelets ≥100,000/mm3 or 100×109/L
✓. For oligodendroglioma: Have local testing at an accredited laboratory demonstrating presence of 1p19q co deletion
✓. For astrocytoma: Have local testing by an accredited laboratory demonstrating lack of 1p19q co-deletion and/or documented loss of nuclear ATRX expression or ATRX mutation
✓. Serum total bilirubin ≤1.5×upper limit of normal (ULN); if ≥1.5×ULN and due to Gilbert syndrome, total bilirubin ≤3×ULN with direct bilirubin ≤ULN,
✓. AST and ALT ≤ULN, and
✓. Alkaline phosphatase ≤2.5×ULN.
Exclusion criteria
✕. curatively resected non-melanoma skin cancer, or
✕. curatively treated carcinoma in situ. Participants with other previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
What they're measuring
1
Phase 1b ONLY: Dose-limiting toxicities (DLTs)
Timeframe: Through cycle 1 (each cycle is 28 days)
2
Number and severity of adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESIs)
Timeframe: Through 30 days after the end of treatment (Approximately 3 years)
3
Progression-free Survival (PFS) status at 12 months
Timeframe: 12 months after treatment initiation
Trial details
NCT IDNCT06478212
SponsorInstitut de Recherches Internationales Servier
✕. Have received prior systemic anti-cancer therapy (other than surgery) within 1 month (or 6 weeks for nitrosoureas and 6 months for TMZ) of the start of study treatment. In addition, the first dose of study treatment should not occur before a period of 28 days or ≥5 half-lives of any prior investigational agent have elapsed, whichever is longer.
✕. Have received more than one prior line of therapy for glioma (Note: prior RT + chemotherapy is considered one line of therapy).