NCT06001788 Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT06001788 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kura Oncology, Inc. |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 171 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 171 participants in total. It began in 2024-02-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Eligibility Criteria
Key Inclusion Criteria: * 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06001788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06001788 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06001788 currently recruiting?
Yes, NCT06001788 is actively recruiting participants. Contact the research team at medinfo@kuraoncology.com for enrollment information.
Where is the NCT06001788 trial being conducted?
This trial is being conducted at Gilbert, United States, Los Angeles, United States, Los Angeles, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT06001788 clinical trial?
NCT06001788 is sponsored by Kura Oncology, Inc.. The trial plans to enroll 171 participants.