Spots Global Cancer Trial Database for Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS

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Trial Identification

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

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

Study ID: NCT03187288

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Relapsed Cancer

Refractory Cancer

Interventions

CFI-400945 Fumarate

Study Description

Brief 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.

Detailed Description: Participants will be screened prior to the start of the study drug for eligibility. Eligible participants will take CFI-400945 by mouth, once a day, every day of each 28 day cycle. Participants will be asked to keep a study drug diary. While receiving the study drug, participants will have standard tests and procedures done for safety purposes. Procedures for research purposes include bone marrow aspirate and additional blood collection for biomarker research, and additional blood samples for pharmacokinetic research. When participants stop the study drug permanently for any reason, they will be asked to have an End of Treatment Visit and be followed for safety purposes.