CLINICAL TRIALS PROFILE FOR OLUTASIDENIB
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All Clinical Trials for OLUTASIDENIB
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02719574 ↗ | Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation | Recruiting | Forma Therapeutics, Inc. | Phase 1/Phase 2 | 2016-04-01 | This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. |
| NCT06161974 ↗ | Study of Olutasidenib and Temozolomide in HGG | Not yet recruiting | Nationwide Children's Hospital | Phase 2 | 2024-06-01 | 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. |
| NCT06161974 ↗ | Study of Olutasidenib and Temozolomide in HGG | Not yet recruiting | Rigel Pharmaceuticals | Phase 2 | 2024-06-01 | 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. |
| NCT06445959 ↗ | Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib | RECRUITING | Rigel Pharmaceuticals,Inc. | PHASE1 | 2024-08-29 | To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML. |
| NCT06445959 ↗ | Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib | RECRUITING | M.D. Anderson Cancer Center | PHASE1 | 2024-08-29 | To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML. |
| NCT06543381 ↗ | Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant | RECRUITING | National Cancer Institute (NCI) | PHASE1 | 2025-01-17 | This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and/or effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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