← Back to Search

Other

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
Patients must be >18 years of age
For Parts 1A and 1B, patients with relapsed or refractory AML, MDS after prior hypomethylating agents, and CMML with progressive disease/lack of response after hypomethylating agents are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

TWT-202 Trial 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.Check my eligibility
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.See study design
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.

TWT-202 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.
Select...
My AML, MDS, or CMML has not improved after treatment with hypomethylating agents.
Select...
I am fully active or can carry out light work.

TWT-202 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

TWT-202 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
157 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this experiment?

"Clinicaltrials.gov shows that this medical trial is actively seeking participants, having initially been posted in April 2021 and recently modified on July 2022."

Answered by AI

How many participants is the research team currently recruiting for this trial?

"In order to successfully complete the trial, 72 eligible patients must be recruited. This endeavor is being conducted by Treadwell Therapeutics, Inc across multiple sites including University of Alberta located in Edmonton and New york Presbyterian Weill Cornell Medical Center situated in New York City."

Answered by AI

How many venues are hosting this trial's proceedings?

"Seven medical centres are conducting this clinical trial, such as The University of Alberta in Edmonton, New york Presbyterian Weill Cornell Medical Center in NYC and the Ohio State University Comprehensive Cancer Centre. There are also four other locations taking part."

Answered by AI

What is the desired result of conducting this experiment?

"This three year trial will monitor the efficacy of CFI-400945 in treating Myelodysplastic syndrome, Chronic myelomonocytic leukemia, and Acute myeloid leukaemia. Primary outcomes include changes to clinical laboratory tests while secondary assessments measure overall response rate (ORR), area under curve (AUC) values for pharmacokinetics, and maximum plasma concentrations at Tmax (Cmax)."

Answered by AI

To what primary purpose is CFI-400945 typically administered?

"CFI-400945 is a potent drug that can be leveraged for induction chemotherapy. Additionally, it has been tested to treat intermediate-2 ipss risk category cases, refractory anemias and acute myelocytic leukemia."

Answered by AI

Could you elaborate on the other investigations involving CFI-400945?

"At this moment, 263 studies are examining the effects of CFI-400945 with 46 trials in their final stage. Most research is conducted at Reggio Emilia and Foggia; however, there are 6546 sites currently running experiments on CFI-400945."

Answered by AI
~27 spots leftby Jan 2026