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CFI-400945 Fumarate for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Karen Yee, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing an investigational drug to treat relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. The goal is to find the best dose that is safe and tolerable for patients.

Who is the study for?
Adults who can take pills, with relapsed or refractory AML or MDS after certain treatments, not pregnant, willing to use contraception and provide consent. Excluded if they have chronic infections, serious illnesses, recent cancer therapies without recovery from side effects, active CNS leukemia, HIV/HBV/HCV infection, recent heart issues or surgery.Check my eligibility
What is being tested?
The trial is testing the safety and tolerability of CFI-400945 Fumarate in patients with specific types of blood cancers that have returned or didn't respond to treatment. It aims to find the highest dose patients can take without severe side effects.See study design
What are the potential side effects?
Since this is a phase 1 study primarily focused on dosage and safety assessment for CFI-400945 Fumarate in blood cancers like AML/MDS, specific side effects are being determined but may include typical drug reactions such as nausea, fatigue, and potential blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My leukemia or MDS has come back or didn't respond to treatment.
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I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of the frequency and severity of treatment-emergent adverse events in patients
Highest tolerated dose of CFI-400945 fumarate
Recommended phase 2 dose of CFI-400945 fumarate
Secondary outcome measures
Number of participants with response to treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: CFI-400945Experimental Treatment1 Intervention
CFI-400945 will be given by mouth at 64,96,128,160,192 or 224 mg/day, everyday until intolerable side effects or disease progression.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,477 Total Patients Enrolled
Karen Yee, M.D.Principal InvestigatorPrincess Margaret Cancer Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS
2018. "Study of CFI-400945 Fumarate in Patients With Relapsed or Refractory AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03187288.
~2 spots leftby Apr 2025
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