Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS

• Status: Recruiting
• Trial end date: 2022-04-04
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 study of investigational drug CFI-400945 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. The purpose of this phase 1 study is to see how safe and tolerable the study drug is and to determine the best dose (maximum tolerated dose or recommended phase 2 dose) that can be given in this patient population.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto

Criteria

Inclusion Criteria:

• 18 years of age or older

• Relapsed and/or refractory myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that meets certain criteria for prior treatments

• Have acceptable circulating blasts count

• Have clinically acceptable laboratory blood and urine test results

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

• Be able to swallow oral medications

• Have a life expectancy of 3 months or more

• Agree to use highly effective means of contraception during a defined period

• Negative serum pregnancy test before the start of the study drugs

• Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, provide a blood and bone marrow sample for genetic testing and agree to return for the required assessments

Exclusion Criteria:

• Have received cancer therapies within 14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug or have not recovered from toxicities from prior treatments

• Not recovered from toxicities related to allogeneic transplant

• Known active extramedullary central nervous system (CNS) AML

• Secondary cancer needing therapy with exceptions

• Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

• Known significant mental illness or other condition that may affect the ability to follow the requirements of the study

• Have a chronic infection

• Have uncontrolled severe hypertension

• Have symptomatic congestive heart failure

• Have active angina pectoris or recent myocardial infarction

• Have chronic atrial fibrillation or unacceptable QTc

• Have had major surgery within 21 days of starting therapy

• Have additional uncontrolled serious medical or psychiatric illness

• Have any medical condition that would affect taking the study drug

• Receiving treatment with full dose warfarin

• Receiving treatment with drugs not allowed in this study

• Women who are pregnant or lactating.