First Human Study of Ziftomenib for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia

Sponsor: Kura Oncology, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04067336

Provider View

This clinical trial is testing a new drug, ziftomenib, to see if it is safe and effective for patients with acute myeloid leukemia (AML) that has returned or is not responding to treatment. The study will also explore its effects on a specific type of AML with a genetic mutation called NPM1-m.

Patient Parameters

Program Overview

This study is the first to test ziftomenib, a new drug, in humans. It aims to find out if ziftomenib is safe and can help treat patients with acute myeloid leukemia (AML) that has come back or is not responding to other treatments. The study is divided into two phases. Phase 1 will focus on finding the right dose and checking for any side effects. Phase 2 will continue to test the drug in patients with a specific genetic mutation in their AML, known as NPM1-m, to see how well it works against the cancer.

Description

This clinical trial is designed to test a new drug called ziftomenib in patients with acute myeloid leukemia (AML) that has either returned after treatment or is not responding to current treatments. The study is divided into two parts:

  • Phase 1: This part will determine the safest dose of ziftomenib and check for any side effects. It will also explore how the drug affects the cancer in patients with specific genetic changes in their leukemia cells.

  • Phase 2: This part will focus on patients with a specific genetic mutation in their AML, called NPM1-m, to see if ziftomenib can effectively reduce the cancer.

The study will help researchers understand the safety and potential benefits of ziftomenib for treating AML.

Eligibility Criteria

Inclusion Criteria

  • Have acute myeloid leukemia (AML) that has returned or is not responding to treatment, with at least 5% cancer cells in the bone marrow.
  • Be 18 years or older.
  • Have a specific genetic change in the leukemia cells, such as KMT2A-r or NPM1-m.
  • Be in good overall health with a life expectancy of at least 2 months.
  • Have good liver and kidney function.
  • Have a white blood cell count of 30,000/μL or less, with medication allowed to control it before joining the study.
  • Women who can become pregnant must use effective birth control during the study and for 180 days after the last dose.
  • Men with partners who can become pregnant must use effective birth control during the study and for 90 days after the last dose.

Exclusion Criteria

  • Have a type of leukemia called acute promyelocytic leukemia or chronic myelogenous leukemia in blast crisis.
  • Have active leukemia in the central nervous system.
  • Have not fully recovered from a stem cell transplant.
  • Have received certain treatments or investigational drugs recently.
  • Have not recovered from previous treatment side effects.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have serious heart conditions or recent heart attacks.
  • Have had major surgery recently.
  • Be pregnant or breastfeeding.

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