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Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06001788
Protocol IDs
KO-MEN-008 (primary)
NCI-2023-06933
Study Sponsor
Kura Oncology, Inc.

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

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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.