JPRN-jRCT2080223194已完成1 期
A Phase 1/1b, Open-label Study of Pevonedistat (MLN4924, TAK-924) as Single Agent and in Combination With Azacitidine in Adult East Asian Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
研究概览
简要总结
The recommended clinical dose of pevonedistat in combination with azacitidine in East Asian participants was determined to be pevonedistat 20 mg/m^2 administered on Days 1, 3, and 5 plus azacitidine 75 mg/m^2 on Days 1 through 5, 8, and 9 in a 28-day cycle. -The recommended phase 2/phase 3 dose (RP2/3D) of pevonedistat 20 mg/m^2 in combination with azacitidine 75 mg/m^2 in East Asian participants was the same as determined in Western patient population.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. East Asian patients aged 18 years or older (or minimum age of legal consent consistent with local regulations) when written study informed consent is obtained must meet 1 of the following diagnosis criteria for either the Single-Agent Arm or the Combination Arm (additional restrictions apply to the Single Agent Arm):
- •- Are male and female participants with WHO-defined AML, including leukemia secondary to prior chemotherapy or resulting from an antecedent hematologic disorder, who have failed to achieve CR or who have relapsed after prior therapy (R/R) and are not candidates for potentially curative treatment, or
- •- Are male and female participants aged 60 years or older with previously untreated AML who have bone marrow blasts <30% and who are not candidates for standard induction chemotherapy, or
- •- Are male and female participants with WHO-defined MDS that meets the IPSS-R criteria for the very high, high, or intermediate risk group, for whom standard curative, life-prolonging treatment does not exist or is no longer effective (R/R), or
- •- Are male and female participants with previously untreated MDS that meets the IPSS-R criteria for the very high, high, or intermediate risk group, or
- •- Are male and female participants with WHO-defined CMML-2 or CMML-1 that meets the IPSS-R criteria for the very high, high, or intermediate risk group CMML-1 participants must have bone marrow blasts >=5%.
- •2. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •3. Able to undergo bone marrow aspiration and biopsy at Screening.
排除标准
- •1. Acute promyelocytic leukemia (as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics [t (15:17)] of peripheral blood or bone marrow, or by other accepted analysis) or AML associated with t (9;22) karyotypes or molecular.
- •2. More than 3 prior lines of therapy (Combination Arm only).
- •3. Prior therapy with hypomethylating agents (example, azacitidine, decitabine) (Combination Arm only).
- •4. Is eligible for a hematopoietic stem cell transplant.
- •5. Is a female participant who is lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.
- •6. Had treatment with any investigational products within 14 days before the first dose of any study drug.
- •7. Has known hypersensitivity to azacitidine or mannitol (Combination Arm only).
- •8. Has known central nervous system involvement.
- •9. Had systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of any study drug, except for hydroxyurea.
研究者
相似试验
已完成
2 期
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)Myelodysplastic SyndromesLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, AcuteNCT02610777Millennium Pharmaceuticals, Inc.120
已完成
2 期
Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase InhibitorsMyelodysplastic SyndromesMyeloproliferative NeoplasmNCT03238248Vanderbilt-Ingram Cancer Center71
已完成
3 期
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)Leukemia, Myelomonocytic, ChronicLeukemia, Myeloid, AcuteMyelodysplastic SyndromeNCT03268954Takeda454
已完成
1 期
A Study of Pevonedistat in Adult East Asian ParticipantsLeukemia, Myeloid, AcuteMyelodysplastic SyndromesNCT02782468Millennium Pharmaceuticals, Inc.23
已完成
2 期
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive ChemotherapyAcute Myeloid Leukemia (AML)NCT04266795Takeda164