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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04730258
Other study ID # TWT-202
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 16, 2021
Est. completion date January 2026

Study information

Verified date April 2024
Source Treadwell Therapeutics, Inc
Contact Treadwell Therapeutics Clinical Trials
Phone +1-416-455-7510
Email clinicaltrials@treadwelltx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients must be >18 years of age 2. For Parts 1A and 1B, the following malignancy types will be included: 1. Relapsed or refractory AML. 2. MDS, after prior hypomethylating agents. 3. CMML, with progressive disease/lack of response after hypomethylating agents For Parts 1A and 1B, Patients may have relapsed or refractory disease. 3. For Parts 2A and 2B, the following malignancy types will be included: 1. Relapsed or Refractory AML. 2. MDS patients should be limited to high risk disease 3. MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease; 4. Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter) 2. 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. 3. Any Grade = 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CFI-400945
The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
Azacitidine
Azacitidine will be given at its labeled dose and schedule

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada Princess Margaret Cancer Center Toronto Ontario
Hong Kong Queen Mary Hospital Hong Kong
United States The Ohio State University Comprehensive Cancer Center Columbus Ohio
United States City of Hope Duarte California
United States The University of Texas MD Anderson Cancer Centre Houston Texas
United States Norton Cancer Institute - Saint Matthews Louisville Kentucky
United States New York Presbyterian Weill Cornell Medical Center New York New York
United States University of California Davis Comprehensive Cancer Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Treadwell Therapeutics, Inc

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment emergent AEs The number of subjects who experience an adverse event that was possibly related to study drug 36 months
Primary Treatment emergent changes in vital signs 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
Primary Treatment emergent changes in clinical laboratory tests The number of subjects who experience a change in laboratory parameters that was possibly related to study drug. 36 months
Primary Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug. 36 months
Secondary Composite Complete Remission Rate, CRc (complete remission + complete remission with incomplete blood count recovery + complete remission with incomplete platelet count recovery [CR + CRi + CRp]) Response rate will be summarized by dose cohort and overall using the percent of patients in patient with AML 36 months
Secondary Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI) Response rate will be summarized by dose cohort and overall using the percent of patients in patients with MDS, CMML 36 months
Secondary The pharmacokinetics of CFI-400945 will be assessed through AUC. Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group. 36 months
Secondary To assess the pharmacokinetic profile of CFI-400945 through Cmax. Cmax will be assessed through the maximum measured plasma concentration occurring at Tmax tabulated by dose group. 36 months
Secondary To assess the pharmacokinetic profile of CFI-400945 through T1/2. Elimination half life will be calculated and tabulated by dose group. 36 months
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