Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olutasidenib Investigational Agent Administration · 1 trial · 1 indication
Feasibility defined as the number of participants with 75% protocol treatment compliance for a duration of at least 4 cycles (to include protocol defined dose delays), or until disease relapse or allogeneic hematopoietic stem cell transplant (alloHCT).
Incidence of grade ≥4 adverse events (AEs) attributable to study drug for duration of treatment on study
| Arm | Type | Description |
|---|---|---|
| Olutasidenib Investigational Agent Administration | EXPERIMENTAL | 150 mg by mouth twice daily. |
| Name | Type | Description |
|---|---|---|
| Olutasidenib Investigational Agent Administration | DRUG | Twice daily olutasidenib maintenance therapy |
Inclusion Criteria: * Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment....
Olutasidenib Investigational Agent Administration is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated in patients with IDH1-mutant AML.
Olutasidenib Investigational Agent Administration is a kinase inhibitor, as indicated by its '-nib' suffix. It is being studied in biomarker-selected patients with IDH1 mutations. The drug is intended to target the mutated IDH1 enzyme in Acute Myeloid Leukemia, though specific molecular details are not provided.
Olutasidenib Investigational Agent Administration is being developed by Rigel Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RIGL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia.
Olutasidenib Investigational Agent Administration is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for any use. The ongoing Phase 1 trial is currently recruiting participants to study the drug in Acute Myeloid Leukemia.
Olutasidenib Investigational Agent Administration is being studied in one active Phase 1 clinical trial with the identifier NCT07130695. The trial, titled 'Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation,' is recruiting 15 participants in the United States. It is an uncontrolled, non-randomized, open-label study.
Olutasidenib Investigational Agent Administration is a formulation or administration method of the drug olutasidenib. The clinical trial NCT07130695 evaluates olutasidenib as a single agent and in combination therapy. The drug is being developed by Rigel Pharmaceuticals for Acute Myeloid Leukemia.