M.D. Anderson Cancer Center
The goal of this clinical research study is to find the recommended dose of monzosertib in patients with relapsed/refractory AML and high-risk MDS. The safety and effects of monzosertib will also be studied.
Primary Objective: To study the safety and tolerability of monzosertib in terms of treatment emergent adverse events (TEAE) and dose limiting toxicities (DLT). To establish the RP2D of monzosertib based on the totality of the data. Secondary Objectives: 1. To estimate rate of CR/CRh by 4 cycles of treatment 2. To estimate overall response rate (ORR) by 4 cycles of treatment. ORR will be defined as CR/CRh/CRi/MLFS/PR for AML and MDS/AML, and CR/CR equivalent/PR/CRL/CRh/HI for MDS or CMML 3. To determine duration of response (DOR) of CR/CRh 4. To determine overall survival (OS) Exploratory…
Inclusion Criteria: 1. Patients need to be adults ≥18 years with R/R AML, 'MDS/AML', MDS, or CMML, per the ICC 2022 or the WHO 2022 with ≥5% blasts at screening. 6,7 2. Relapsed or refractory disease is defined as: patient having received and have progressed or relapsed or intolerant to standard regimens, e.g., as listed in NCCN guidelines, or declined treatment with such therapies. a. This may include at least one cycle of intensive chemotherapy for AML, or for AML/MDS/CMML at least 2 cycles of BCL2 inhibitor based lower intensity regimen or 4 cycles of HMA-based regimens without BCL2 in…
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