A Study of CFI-400945 With or Without Azacitidine or Decitabine in Patients With AML, MDS or CMML

Official Title

Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine or Decitabine in Patients With AML, MDS or CMML

Summary:

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine or decitabine

Trial Description

Primary Outcome:

• Incidence of treatment emergent AEs
• Treatment emergent changes in vital signs
• Treatment emergent changes in clinical laboratory tests
• Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins

Secondary Outcome:

• Composite Complete Remission Rate, CRc (complete remission + complete remission with incomplete blood count recovery + complete remission with incomplete platelet count recovery [CR + CRi + CRp])
• Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI)
• The pharmacokinetics of CFI-400945 will be assessed through AUC.
• To assess the pharmacokinetic profile of CFI-400945 through Cmax.
• To assess the pharmacokinetic profile of CFI-400945 through T1/2.

This study will be evaluating the safety and tolerability of CFI-400945 in subjects with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. The study is designed to build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.

View this trial on ClinicalTrials.gov