A Phase Ib Rising Multiple-Dose Clinical Study to Evaluate Safety, Tolerability, and Activity of Oral Monotherapy with KX2-391 in Elderly Subjects with Acute Myeloid Leukemia (AML) Who Are Refractory to or Have Declined Standard Induction Therapy

Study Status

Open to Enrollment

Study Description

This is a clinical trial for patients with Acute Myeloid Leukemia (AML), age 60 or older, who have either never received treatment for their AML or whose AML has not responded to one or two courses of treatment (relapsed or refractory AML).

KX2-391 is a new experimental drug designed to block proteins that are thought to be necessary for cancer cells to grow and spread. This drug may help slow the growth of tumors.

The purpose of this study is to determine the highest dose of KX2-391 that can safely be given to patients with AML who are age 60 or older, and to begin to understand how well KX2-391 works as a treatment for AML.

KX2-3911 is a liquid that is taken orally. Patients will receive 1 dose daily of the study drug. The dose you receive will be based on how many patients have been enrolled before you.

Once the highest dose of KX2-391 is found, you will have the option to continue your treatment or discuss alternative treatment options with your physician. If you and your physician feel the study drug has helped you, you will be allowed to continue treatment so long as you do not develop side effects that cannot be controlled.

Disease Status and/or Stage

Acute Myeloid Leukemia (AML) in Subjects Age 60 and Older



Key Eligibility

  • Men and women age 60 and older
  • Acute Myeloid Leukemia (AML)
  • No more than 2 previous courses of AML remission-induction chemotherapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ellen Ritchie, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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