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Therapy Name | Azacitidine + Olutasidenib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Azacitidine | Vidaza | azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg | DNMT inhibitor (Pan) 5 | Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov). |
Olutasidenib | Rezlidhia | FT-2102 | IDH1 Inhibitor 8 | Rezlidhia (olutasidenib) targets IDH1 R132 mutations, leading to decreased 2HG production and potentially promoting differentiation and decreasing proliferation of IDH R132-mutant cancer cells (PMID: 31971798). Rezlidhia (olutasidenib) is FDA approved for use in adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT06597734 | Phase II | Decitabine and Cedazuridine + Olutasidenib Azacitidine + Olutasidenib Decitabine + Olutasidenib | A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm | Not yet recruiting | USA | 0 |
NCT02719574 | Phase I | Cytarabine + Olutasidenib Olutasidenib Azacitidine + Olutasidenib | Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 1 |
NCT03684811 | Phase Ib/II | Cisplatin + Gemcitabine + Olutasidenib Azacitidine + Olutasidenib Olutasidenib Nivolumab + Olutasidenib | A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation | Completed | USA | GBR | FRA | ESP | AUS | 1 |