Search Cancer Clinical Trials
Recruiting
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib (KO-539), a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML).
- Advanced Malignant Neoplasm
- Acute Myeloid Leukemia
- Mixed Lineage Leukemia
- Mixed Lineage Acute Leukemia
- Acute Leukemia of Ambiguous Lineage
- Mixed Phenotype Acute Leukemia
- Ziftomenib
Phase 1/Phase 2
Interventional
Primary Outcome:
- Part 1a: Maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
- Part 1b: Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Part 1b: Minimal biologically effective dose
Secondary Outcome:
- Part 1a: Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Part 1a: Tmax
- Part 1a: AUC(0-last)
- Part 1a: Cmax
- Parts 1a and 1b: Composite definition of complete remission (CR) and complete remission with partial hematologic recovery (CRh)
- Parts 1a and 1b: Complete response (CR) with and without minimal residual disease (MRD)
- Parts 1a and 1b: Duration of remission (DOR)
- Part 1b: Transfusion independence (TI)
- Part 1b: Relapse-free survival (RFS)
- Part 1b: Overall survival
60
September 12, 2019
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Kura Oncology, Inc.
Kura Oncology, Inc.
A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT04067336
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.