Study of Olutasidenib and Temozolomide in HGG (NCT06161974) | Clinical Trial Compass
RecruitingPhase 2
Study of Olutasidenib and Temozolomide in HGG
United States60 participantsStarted 2025-03
Plain-language summary
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.
The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
Who can participate
Age range12 Years – 39 Years
SexALL
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Inclusion criteria
✓. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:
✓.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR
✓.2) Diagnosis:
✓.3) Disease status: There are no disease status requirements for enrollment
✓. Inclusion criteria for assignment to TarGeT-D, for all strata:
✓.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:
✓.2 Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
✓.3 Prior Therapy
Exclusion criteria
✕. Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown potential risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of childbearing or child fathering potential must agree to use one highly effective method of contraception while being treated on this study and for 3 months after completing therapy. A woman is considered of childbearing potential if she is fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. Male participants should refrain from sperm donation throughout the duration of treatment and for 3 months after completion of therapy.
What they're measuring
1
Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort)
Timeframe: Completion of cycle 1 (28 days) for 6-24 patients
2
Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A)
Timeframe: From date of diagnosis until date of Progressive Disease or death due to any cause or date of last follow-up, assessed up 24 months
3
Maximum plasma concentration [Cmax] of Olutasidenib
Timeframe: From Day 1 of treatment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months