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A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination with Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients with AML

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05735184
Protocol IDs
KO-MEN-007 (primary)
NCI-2023-04854
Study Sponsor
Kura Oncology Inc

Summary

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic
activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and
7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

Eligibility

  1. Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  3. Adequate liver, renal, and cardiac function according to protocol defined criteria
  4. A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention Key

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University


1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

**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.