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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has been diagnosed with relapsed/refractory AML. - Has a documented NPM1 mutation or KMT2A rearrangement. - Has a documented FLT3 mutation (cohort A-3 only). - Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2. - Has adequate hepatic and renal function as defined per protocol. - Has an ejection fraction above a protocol defined limit. - Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. - Has agreed to use contraception as defined per protocol.

Exclusion Criteria

  • Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia. - Has clinically active central nervous system leukemia. - Has an active and uncontrolled infection. - Has a mean corrected QT interval (QTcF) > 480ms. - Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. - Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy <14 days or within 5 drug half-lives prior to the first dose of study intervention. - Has had major surgery within 4 weeks prior to the first dose of study intervention. - Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria. - Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD. - Participant is pregnant or lactating.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1a 		Oral 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)
  • Drug: Ziftomenib
    Oral administration
    Other names:
    • KO-539
  • Drug: Fludarabine
    Intravenous infusion
  • Drug: Idarubicin
    Intravenous infusion
  • Drug: Cytarabine
    Intravenous Infusion
  • Drug: Gilteritinib
    Oral administration
    Other names:
    • Xospata
  • Biological: Granulocyte colony-stimulating factor
    Subcutaneous injection
Experimental
Phase 1b 		Oral 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)
  • Drug: Ziftomenib
    Oral administration
    Other names:
    • KO-539
  • Drug: Fludarabine
    Intravenous infusion
  • Drug: Idarubicin
    Intravenous infusion
  • Drug: Cytarabine
    Intravenous Infusion
  • Drug: Gilteritinib
    Oral administration
    Other names:
    • Xospata
  • Biological: Granulocyte colony-stimulating factor
    Subcutaneous injection

Recruiting Locations

The University of Kansas
Kansas City, Kansas 66160
Contact:
KUCC Navigation Team
913-588-3671
kucc_navigation@kumc.edu

More Details

Status
Recruiting
Sponsor
Kura Oncology, Inc.

Study Contact

Clinical Operations
858 500 8800
KO-MEN-008@kuraoncology.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.