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Title
Status

 

CFI-400945-AML-201/TWT-202 - 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

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CFI-400945-AML-201/TWT-202 - 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

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DiagnosisAcute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)Study StatusOpen
PhaseI/II
Age18 Years and older RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: CFI-400945 (oral) Arm 2A only: Azacitidine (IV)
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04730258
International Sponsor
Treadwell Therapeutics, Inc
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

Study Description

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

Inclusion Criteria
  • Patients must be >18 years of age
  • Patients must have a qualifying diagnosis of Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) that has come back or not responded to other treatment
  • Have acceptable laboratory screening results within certain limits
  • Be able to carry out light daily work with little/no restriction

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team