Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Refractory Acute Myeloid Leukemia Clinical Trial

Official title: Phase 1 Study of IACS-010759 in Subjects With Relapsed or Refractory AML

Status Terminated

Clinical Trial Summary

This phase I trial studies the side effects and best dose of oxidative phosphorylation inhibitor IACS-010759 in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Oxidative phosphorylation inhibitor IACS-010759 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined the study. Up to 6 groups of 3-6 participants will be enrolled in the dose escalation part of the study. Up to 18 participants will be enrolled in dose expansion.

OUTLINE: This is a dose-escalation study.

INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 orally (PO) once daily (QD) on days 1-7.

MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of course 1 and on days 1, 8, and 15 of subsequent courses. Treatment repeats every 21 days for subsequent courses for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of oxidative phosphorylation inhibitor IACS-010759 at the discretion of study doctor.

After completion of study treatment, patients are followed up every 3-6 months for up to 5 years.

If you are enrolled in dose escalation, the dose of IACS-010759 you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of IACS-010759. Each new group will receive a higher dose of IACS-010759 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of IACS-010759 is found.

If you are enrolled in the dose expansion part of the study, you will receive the dose level of IACS-010759 that was found to be the best dose in the escalation part of the study.

In the dose expansion part of the study, 6 participants will also be enrolled in a food-effect group (described in more detail below) to help researchers understand the effects of taking the study drug with food.

Study Drug Administration Each study cycle is 21 days. Cycle 1 only is 28 days. You will take IACS-010759 by mouth one (1) time every day. On Day 1 of Cycle 1 only, you will take your first dose of IACS-010759 and then wait 7 days to take your next dose. Starting on Day 8 of Cycle 1, you will take the study drug every day for the next 21 days.

You will be admitted to the hospital on Day 1 of Cycle 1 for 24 hours and on Day 8 of Cycle 1 for 7 days. This is done so that you can be checked on for any side effects.

Length of Study You may continue to take IACS-010759 for up to 12 cycles. If the doctor thinks it is in your best interest, you may be able to continue receiving the study drug beyond 12 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

• NCT number: NCT02882321
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1
• Start date: September 29, 2016
• Completion date: April 15, 2022