Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
第1/2相
完了
NCT02719574
| 対象疾患 | Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome |
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| 相 | 第1/2相 |
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| スポンサー | Forma Therapeutics, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 336 名 |
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| 介入（薬剤） | FT-2102 (olutasidenib), Azacitidine, Cytarabine |
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| 開始日 | 2016年4月30日 |
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| 完了日 | 2023年12月28日 |
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| 結果公開日 | 2025年6月26日 |
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概要
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.
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months) · Participants
| Phase 1: FT-2102 (Single Agent) | 16 Participants |
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| Phase 1: Total FT-2102 (Single Agent) | 31 Participants |
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| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 39 Participants |
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| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 46 Participants |
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| Phase 1: FT-2102 (Single Agent) | 10 Participants |
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| Phase 1: Total FT-2102 (Single Agent) | 23 Participants |
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Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months) · Participants
| Phase 1: FT-2102 (Single Agent) | 15 Participants |
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| Phase 1: Total FT-2102 (Single Agent) | 30 Participants |
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| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 38 Participants |
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| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 45 Participants |
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| Phase 1: FT-2102 (Single Agent) | 0 Participants |
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| Phase 1: Total FT-2102 (Single Agent) | 0 Participants |
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Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months) · Participants
| Phase 1: FT-2102 (Single Agent) | 10 Participants |
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| Phase 1: Total FT-2102 (Single Agent) | 16 Participants |
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| Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 23 Participants |
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| Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 26 Participants |
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| Phase 1: FT-2102 (Single Agent) | 4 Participants |
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| Phase 1: Total FT-2102 (Single Agent) | 11 Participants |
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