Myelodysplastic Syndrome Clinical Trial
Official title:
A Phase 1 Study of MLN7243 (TAK-243) for Either Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome/Chronic Myelomonocytic Leukemia Refractory to Hypomethylating Agents
This phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia, or myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back or that is not responding to treatment. TAK-243 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To establish the recommended phase 2 dose (RP2D) of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (MLN7243 [TAK-243]) administered intravenously in a twice-weekly schedule in patients with acute myeloid leukemia (AML) or patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) refractory to hypomethylating agents (HMAs). SECONDARY OBJECTIVES: I. To assess the maximum tolerated dose (MTD) evaluated on the first cycle (Day 1 to 21) of MLN7243 (TAK-243), its safety profile, and dose limiting toxicities (DLT). II. To investigate preliminary anti-leukemic activity of MLN7243 (TAK-243) monotherapy in patients with AML, MDS and CMML. III. To relate responses to the molecular/cytogenetic abnormalities in the malignant cells or to pharmacokinetic (PK)/pharmacodynamic (PD) findings. IV. To describe the PK of MLN7243 (TAK-243). V. To describe the PD profile of MLN7243 (TAK-243) in the study population. VI. To establish the RP2D of MLN7243 (TAK-243) administered intravenously in a once-weekly schedule in patients with AML or patients with MDS or CMML refractory to HMAs. OUTLINE: This is a dose escalation, followed by a dose expansion, study. Patients are assigned to 1 of 2 groups. GROUP I: Patients receive UAE inhibitor TAK-243 intravenously (IV) over 10 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive UAE inhibitor TAK-243 IV over 10 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. ;
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