Conditions: Acute Myeloid Leukemia
Keywords: AML relapsed refractory
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 90
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.

Detailed description:
Protocol PLX108-05 is a Phase 1/2 open-label, sequential dose escalation (Part 1) followed by cohort expansion (Part 2) design at the recommended phase 2 dose established in Part 1 (i.e. 3,000 mg/day). Treatment with PLX3397 will consist of continuous oral administration in 28-day cycles until unacceptable or dose-limiting toxicity, disease progression or relapse, patient death, Investigator decision, or voluntary withdrawal.

Arms:
arm 1: Subjects will be dosed at the recommended Phase 2 dose (RP2D) arm 2: Level 0 arm 3: Level 1 arm 4: Level 2 arm 5: Level 3 arm 6: Level 4 arm 7: Level 5 arm 8: Level 6 arm 9: Level 7

Interventions: intervention 1: PLX3397 intervention 2: PLX3397
Intervention descriptions: intervention 1: Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily. intervention 2: The drug product is available in capsule form, to be taken orally.

Protocol document: