CFI-400945 for Chronic Myelomonocytic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Myelomonocytic Leukemia+4 MoreCFI-400945 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety of CFI-400945, either alone or in combination with azacitidine or decitabine, in people with blood cancer.

Eligible Conditions
  • Chronic Myelomonocytic Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: 36 months

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

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

2A: Combination escalation and expansion
1 of 4
1A: Monotherapy escalation and expansion
1 of 4
1B: Food Effect
1 of 4
2B: Combination escalation and expansion
1 of 4

Experimental Treatment

72 Total Participants · 4 Treatment Groups

Primary Treatment: CFI-400945 · No Placebo Group · Phase 1 & 2

2A: Combination escalation and expansionExperimental Group · 2 Interventions: CFI-400945, Azacitidine · Intervention Types: Drug, Drug
1A: Monotherapy escalation and expansion
Drug
Experimental Group · 1 Intervention: CFI-400945 · Intervention Types: Drug
1B: Food Effect
Drug
Experimental Group · 1 Intervention: CFI-400945 · Intervention Types: Drug
2B: Combination escalation and expansionExperimental Group · 2 Interventions: CFI-400945, Decitabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CFI-400945
2014
Completed Phase 1
~50
Azacitidine
FDA approved
Decitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Treadwell Therapeutics, IncLead Sponsor
3 Previous Clinical Trials
231 Total Patients Enrolled
Gautam Borthakur, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Centre
6 Previous Clinical Trials
168 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have clinical chemistry, hematology, and urinalysis results within certain limits per protocol.
Patients must be >18 years of age.\n
You have MDS after prior hypomethylating agents.
You have relapsed or refractory acute myeloid leukemia.
You have previously untreated or relapsed/refractory MDS or CMML.
You have an ECOG performance status of 0 or 1.