Search Cancer Clinical Trials
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML.
- Advanced Malignant Neoplasm
- Acute Myeloid Leukemia
- Mixed Lineage Leukemia
- Mixed Lineage Acute Leukemia
- Acute Leukemia of Ambiguous Lineage
- Mixed Phenotype Acute Leukemia
Phase 1/Phase 2
- Phase 1a: Maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
- Phase 1b: Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Phase 1b: Minimal biologically effective dose
- Phase 2: Evidence of anti-leukemia activity
- Phase 1a: Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Phase 1a: Tmax
- Phase 1a: AUC(0-last)
- Phase 1a: Cmax
- Phases 1a, 1b, and 2: Composite definition of complete remission (CR) and complete remission with partial hematologic recovery (CRh)
- Phases 1a, 1b, and 2: Complete response (CR) with and without minimal residual disease (MRD)
- Phases 1a, 1b, and 2: Duration of remission (DOR)
- Phases 1a, 1b, and 2: Transfusion independence (TI)
- Phases 1a, 1b, and 2: Event-free survival (EFS)
- Phases 1a, 1b, and 2: Overall survival
September 12, 2019
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Kura Oncology, Inc.
Kura Oncology, Inc.
A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.