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CFI-400945 + Azacitidine for Leukemia (TWT-202 Trial)

Phase 1 & 2
Recruiting
Led By Gautam Borthakur, MD
Research Sponsored by Treadwell Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
This trial is for adults over 18 with certain blood cancers like AML, MDS, or CMML. It's open to those who have relapsed or didn't respond to previous treatments. Participants should be in good enough health as measured by lab tests and have a performance status of 0 or 1, meaning they are fully active or restricted in physically strenuous activity but can do light work.
What is being tested?
The study is testing the safety of CFI-400945 alone and combined with azacitidine. The participants will either receive just CFI-400945 or both drugs together to see how well they tolerate them and what effect they have on their cancer.
What are the potential side effects?
Potential side effects aren't specified here, but generally, drugs like these could cause fatigue, nausea, vomiting, blood count changes leading to increased infection risk or bleeding problems. Each person may experience side effects differently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment emergent AEs
Treatment emergent changes in clinical laboratory tests
Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins
+1 more
Secondary study objectives
Chromium
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.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2A: Combination escalation and expansionExperimental Treatment2 Interventions
Dose escalation and expansion arm with CFI-400945 and azacitidine
Group II: 1A: Monotherapy escalation and expansionExperimental Treatment1 Intervention
Dose escalation and expansion arm with CFI-400945
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CFI-400945
2014
Completed Phase 1
~50
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

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
114 Total Patients Enrolled

Media Library

CFI-400945 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04730258 — Phase 1 & 2
Myelodysplastic Syndrome Research Study Groups: 1A: Monotherapy escalation and expansion, 2A: Combination escalation and expansion
Myelodysplastic Syndrome Clinical Trial 2023: CFI-400945 Highlights & Side Effects. Trial Name: NCT04730258 — Phase 1 & 2
CFI-400945 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04730258 — Phase 1 & 2
~17 spots leftby Jan 2026
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