A Phase I Study of AMG 397 in Patients with Recurrent or Persistent Multiple Myeloma or Acute Myeloid Leukemia

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Full Title

A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

Purpose

The purpose of this study is to determine the highest dose of the investigational drug AMG 397 that can be given safely in patients with multiple myeloma or acute myeloid leukemia that came back or continues to grow despite prior treatment. AMG 397 is designed to block a protein called MCL1. MCL1 helps cancer cells survive by stopping the normal cell death process called “apoptosis.” By blocking MCL1, AMG 397 may trigger apoptosis in cancer cells and stop tumor growth. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent multiple myeloma or AML.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eytan Stein at 212-639-3314.

Protocol

19-088

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators