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COMPLETED

NCT03187288

PHASE1

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: An Open-Label, Dose Escalation, Safety and Pharmacokinetic Study of CFI-400945 Fumarate Administered Orally to Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-05-25

Completion Date

2021-06-30

Last Updated

2026-09-29

Healthy Volunteers

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes Relapsed Cancer Refractory Cancer

Interventions

DRUG

CFI-400945 Fumarate

CFI-400945 is an investigational drug that is being look at for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CFI-400945 is an oral (taken by mouth) drug that blocks Polo-like kinase 4 (PLK4) activity. PLK4 is a protein that is important in regulating cell growth and division and cell death. Many tumors are shown to make too much PLK4. When there is too much PLK4 produced, it is believed to contribute to uncontrolled cancer cell growth and division. Therefore, by blocking this protein from working, it is believed to stop tumors from growing or shrink them.

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.

Locations (2)

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada