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Protocol # 19-422

Status

Recruiting

Description

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.

Condition

  • Advanced Malignant Neoplasm
  • Acute Myeloid Leukemia
  • Mixed Lineage Leukemia
  • Mixed Lineage Acute Leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Mixed Phenotype Acute Leukemia

Interventions

  • Ziftomenib

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • 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

Secondary Outcome:

  • 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

Enrollment

199

Study Start Date

September 12, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Kura Oncology, Inc.

Source

Kura Oncology, Inc.

Official title

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

Clinicaltrials.gov Identifier

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.