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Also known as Olutasidenib
Olutasidenib+ TMZ · 1 trial · 19 indications
To identify the dose of olutasidenib that is feasible when given post-RT in combination with temozolomide as maintenance therapy in pediatric and young adult patients newly diagnosed with IDH1-mutant high-grade glioma
To assess the post-RT efficacy of olutasidenib in newly diagnosed patients with WHO Grade 3 IDH1-mutant Astrocytoma treated with maintenance olutasidenib and temozolomide for 13 cycles followed by 13 cycles of single agent olutasidenib compared to molecularly-stratified and matched historical controls
To characterize the plasma pharmacokinetic (PK) properties of olutasidenib in pediatric patients (e.g., 12 to \< 18 years of age), administered in combination with temozolomide (first year) and as single agent (second year) as maintenance chemotherapy by measuring the Maximum Concentration \[Cmax\] and Area Under the Curve (AUC) of olutasidenib in plasma (All strata).
| Arm | Type | Description |
|---|---|---|
| Stratum A | EXPERIMENTAL | Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3. |
| Stratum B | EXPERIMENTAL | Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4. |
| Stratum C | EXPERIMENTAL | Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG. |
| Name | Type | Description |
|---|---|---|
| Olutasidenib + TMZ | DRUG | Olutasidenib 150 mg PO BID + Temozolomide 200 mg/m2 PO QD |
Criteria TarGeT-D study strata definitions * Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3. * Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4. * Stra...
Olutasidenib is an investigational small molecule being studied for Acute Myeloid Leukemia with IDH1 mutation and High Grade Glioma. It is in Phase 2 clinical development for these oncology indications.
Olutasidenib is a kinase inhibitor, belonging to the -nib class of drugs. It is being studied in biomarker-selected patients with IDH1 mutations, including subtypes such as IDH1 R132C, R132H, R132S, R132G, and R132L.
Olutasidenib is being developed by Rigel Pharmaceuticals, Inc., which trades under the ticker RIGL. The company is conducting multiple Phase 2 trials for the drug in IDH1-mutated cancers.
Olutasidenib is in Phase 2 clinical development. It is not FDA approved and remains investigational. There are three active or planned Phase 2 trials studying the drug in Acute Myeloid Leukemia and High Grade Glioma.
Olutasidenib is being studied in three Phase 2 trials. NCT06161974 evaluates olutasidenib with temozolomide in High Grade Glioma. NCT06782542 studies olutasidenib with venetoclax and azacitidine in newly diagnosed AML. NCT07471841 examines olutasidenib in relapsed IDH1-mutated AML after venetoclax.
Olutasidenib is the same drug as Olutasidenib plus TMZ, where TMZ refers to temozolomide. The combination name is used in the context of the High Grade Glioma trial NCT06161974, which tests olutasidenib together with temozolomide.