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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Relapsed Cancer; Refractory Cancer

• Registration Number: NCT03187288
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-6-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 years of age or older<br><br> - Relapsed and/or refractory myeloid leukemia (AML) or myelodysplastic syndrome (MDS)<br> that meets certain criteria for prior treatments<br><br> - Have acceptable circulating blasts count<br><br> - Have clinically acceptable laboratory blood and urine test results<br><br> - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2<br><br> - Be able to swallow oral medications<br><br> - Have a life expectancy of 3 months or more<br><br> - Agree to use highly effective means of contraception during a defined period<br><br> - Negative serum pregnancy test before the start of the study drugs<br><br> - Have the ability to understand the requirements of the study, provide written<br> informed consent which includes authorization for release of protected health<br> information, abide by the study restrictions, provide a blood and bone marrow sample<br> for genetic testing and agree to return for the required assessments<br><br>Exclusion Criteria:<br><br> - Have received cancer therapies within 14 days or 5 half-lives (whichever is shorter)<br> prior to first dose of study drug or have not recovered from toxicities from prior<br> treatments<br><br> - Not recovered from toxicities related to allogeneic transplant<br><br> - Known active extramedullary central nervous system (CNS) AML<br><br> - Secondary cancer needing therapy with exceptions<br><br> - Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or<br> hepatitis C virus (HCV) infection<br><br> - Known significant mental illness or other condition that may affect the ability to<br> follow the requirements of the study<br><br> - Have a chronic infection<br><br> - Have uncontrolled severe hypertension<br><br> - Have symptomatic congestive heart failure<br><br> - Have active angina pectoris or recent myocardial infarction<br><br> - Have chronic atrial fibrillation or unacceptable QTc<br><br> - Have had major surgery within 21 days of starting therapy<br><br> - Have additional uncontrolled serious medical or psychiatric illness<br><br> - Have any medical condition that would affect taking the study drug<br><br> - Receiving treatment with full dose warfarin<br><br> - Receiving treatment with drugs not allowed in this study<br><br> - Women who are pregnant or lactating.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the frequency and severity of treatment-emergent adverse events in patients;Highest tolerated dose of CFI-400945 fumarate;Recommended phase 2 dose of CFI-400945 fumarate

Secondary Outcome Measures

Name	Time	Method
Number of participants with response to treatment