NCT04730258

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

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 in Patients With AML, MDS or CMML

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Treadwell Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Chronic Myelomonocytic Leukemia
• AML
• MDS
• CMML

Interventions

Type	Name	Description
DRUG	CFI-400945	The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
DRUG	Azacitidine	Azacitidine will be given at its labeled dose and schedule

Timeline

• Start date: 2021-04-16
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2021-01-29
• Last updated: 2025-05-18

Locations

9 sites across 3 countries: United States, Canada, Hong Kong

Regulatory

• FDA-regulated drug study