Status:
RECRUITING
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Kura Oncology, Inc.
Conditions:
AML
AML With Mutated NPM1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- Has been diagnosed with relapsed/refractory AML.
- Has a documented NPM1 mutation or KMT2A rearrangement.
- Has a documented FLT3 mutation (cA-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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT06001788
Start Date
February 22 2024
End Date
August 1 2027
Last Update
December 3 2025
Active Locations (44)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
3
UCLA Health - Bowyer Oncology Center
Los Angeles, California, United States, 90095
4
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868