Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
Kura Oncology, Inc.
Summary
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Has been diagnosed with relapsed/refractory AML. * Has a documented NPM1 mutation or KMT2A rearrangement. * Has a documented FLT3 mutation (cA-3 only). * Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2. * Has adequate hepatic and renal function as defined per protocol. * Has an ejection fraction above a protocol defined limit. * Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. * Has agreed to use contraception as defined per protocol. Key…
Interventions
- DrugZiftomenib
Oral administration
- DrugFludarabine
Intravenous infusion
- DrugIdarubicin
Intravenous infusion
- DrugCytarabine
Intravenous Infusion
- DrugGilteritinib
Oral administration
- BiologicalGranulocyte colony-stimulating factor
Subcutaneous injection
Locations (45)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- UCLA Health - Bowyer Oncology CenterLos Angeles, California
- UC Irvine Health Chao Family Comprehensive Cancer CenterOrange, California
- University of California San FranciscoSan Francisco, California
- Colorado Blood Cancer InstituteDenver, Colorado