Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Kura Oncology, Inc.
- Study ID
- NCT06001788
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- AML
- AML With Mutated NPM1
- Acute Leukemia
- Acute Myeloid Leukemia
- Hematologic Malignancy
- KMT2Ar
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- MLL Rearrangement
- NPM1 Mutation
- Neoplasms by Histologic Type
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ziftomenib — DRUGOral administration
- Fludarabine — DRUGIntravenous infusion
- Idarubicin — DRUGIntravenous infusion
- Cytarabine — DRUGIntravenous Infusion
- Gilteritinib — DRUGOral administration
- Granulocyte colony-stimulating factor — BIOLOGICALSubcutaneous injection
Study Details
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.
Key Dates
- Start date
- Feb 22, 2024
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 171 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Phase 1aOral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
- Experimental: Phase 1bOral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Primary Outcome Measure
Rate of dose limiting toxicities (DLTs) per dose level [ Time Frame: During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle) ]
Central Contacts
- Kura Medical Information844-KURAONC (844-587-2662)
Locations (38)
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