- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04730258
A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML (TWT-202)
February 2, 2024 updated by: Treadwell Therapeutics, Inc
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
The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will be evaluating the safety and tolerability of CFI-400945 in subjects with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia.
The study is designed to build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Treadwell Therapeutics Clinical Trials
- Phone Number: +1-416-455-7510
- Email: clinicaltrials@treadwelltx.com
Study Locations
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Alberta
-
Edmonton, Alberta, Canada, T6G2B7
- Recruiting
- University of Alberta
-
Contact:
- Joseph Brandwein
-
Contact:
- Brent Howie
- Email: brent.howie@primesiteresearch.com
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Ontario
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Toronto, Ontario, Canada, M5G2C1
- Recruiting
- Princess Margaret Cancer Center
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Contact:
- Karen Yee
-
Contact:
- Hong Song
- Email: hong.song@uhn.ca
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-
-
-
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Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital
-
Contact:
- Keith Chi Yeung Fung
- Email: cyfungad@hku.hk
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Contact:
- Anskar Leung
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-
-
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California
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Duarte, California, United States, 91010
- Recruiting
- City of Hope
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Contact:
- Paul Koller
-
Contact:
- Felicia Lewis
- Email: flewis@coh.org
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Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
-
Contact:
- Brian Jonas, MD
- Email: brian.jonas@ucdmc.ucdavis.edu
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Contact:
- Linh Dang-Chu
- Email: ldangchu@ucdavis.edu
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Kentucky
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Louisville, Kentucky, United States, 40207
- Completed
- Norton Cancer Institute - Saint Matthews
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New York
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New York, New York, United States, 10021
- Recruiting
- New York Presbyterian Weill Cornell Medical Center
-
Contact:
- Gail Roboz
-
Contact:
- Ameenah Sukkur
- Email: ams4015@med.cornell.edu
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Comprehensive Cancer Center
-
Contact:
- Alice Mims
-
Contact:
- Stacey Dillon
- Email: stacey.dillion@osumc.edu
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-
Texas
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas MD Anderson Cancer Centre
-
Contact:
- Gautam Borthakur
- Email: gborthak@mdanderson.org
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must be >18 years of age
For Parts 1A and 1B, the following malignancy types will be included:
- Relapsed or refractory AML.
- MDS, after prior hypomethylating agents.
- CMML, with progressive disease/lack of response after hypomethylating agents
For Parts 1A and 1B, Patients may have relapsed or refractory disease.
For Parts 2A and 2B, the following malignancy types will be included:
- Relapsed or Refractory AML.
- MDS patients should be limited to high risk disease
- MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease;
- Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
- Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
- Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1A: Monotherapy escalation and expansion
Dose escalation and expansion arm with CFI-400945
|
The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
Other Names:
|
Experimental: 2A: Combination escalation and expansion
Dose escalation and expansion arm with CFI-400945 and azacitidine
|
The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
Other Names:
Azacitidine will be given at its labeled dose and schedule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment emergent AEs
Time Frame: 36 months
|
The number of subjects who experience an adverse event that was possibly related to study drug
|
36 months
|
Treatment emergent changes in vital signs
Time Frame: 36 months
|
The number of subjects who experience changes in blood pressure, heart rate, respiratory rate, body temperature that was possibly related to study drug.
|
36 months
|
Treatment emergent changes in clinical laboratory tests
Time Frame: 36 months
|
The number of subjects who experience a change in laboratory parameters that was possibly related to study drug.
|
36 months
|
Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins
Time Frame: 36 months
|
The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite Complete Remission Rate, CRc (complete remission + complete remission with incomplete blood count recovery + complete remission with incomplete platelet count recovery [CR + CRi + CRp])
Time Frame: 36 months
|
Response rate will be summarized by dose cohort and overall using the percent of patients in patient with AML
|
36 months
|
Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI)
Time Frame: 36 months
|
Response rate will be summarized by dose cohort and overall using the percent of patients in patients with MDS, CMML
|
36 months
|
The pharmacokinetics of CFI-400945 will be assessed through AUC.
Time Frame: 36 months
|
Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.
|
36 months
|
To assess the pharmacokinetic profile of CFI-400945 through Cmax.
Time Frame: 36 months
|
Cmax will be assessed through the maximum measured plasma concentration occurring at Tmax tabulated by dose group.
|
36 months
|
To assess the pharmacokinetic profile of CFI-400945 through T1/2.
Time Frame: 36 months
|
Elimination half life will be calculated and tabulated by dose group.
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gautam Borthakur, MD, The University of Texas MD Anderson Cancer Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2021
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 29, 2021
Study Record Updates
Last Update Posted (Estimated)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Myelodysplastic-Myeloproliferative Diseases
- Leukemia, Myeloid
- Chronic Disease
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Azacitidine
Other Study ID Numbers
- TWT-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It is too early to determine whether we will make IPD available - we do not yet have a process written on this.
Field will be updated once our policy / process is written.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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