Trial · NCT04730258
A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML
NCT04730258, Phase 1, Phase 2, Active not recruiting, Treadwell Therapeutics, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML. Trials, record NCT04730258. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04730258
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML
- NCT number
- NCT04730258
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 72 participants, estimated
- Lead sponsor
- Treadwell Therapeutics, Inc
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, AML, MDS, CMML
- Interventions
- CFI-400945, Azacitidine
- First posted
- 2021-01-29
- Last updated
- 2025-05-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment emergent AEs | 36 months | The number of subjects who experience an adverse event that was possibly related to study drug |
| Primary | Treatment emergent changes in vital signs | 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. |
| Primary | Treatment emergent changes in clinical laboratory tests | 36 months | The number of subjects who experience a change in laboratory parameters that was possibly related to study drug. |
| Primary | Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins | 36 months | The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug. |
| 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]) | 36 months | Response rate will be summarized by dose cohort and overall using the percent of patients in patient with AML |
| Secondary | Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI) | 36 months | Response rate will be summarized by dose cohort and overall using the percent of patients in patients with MDS, CMML |
| Secondary | The pharmacokinetics of CFI-400945 will be assessed through AUC. | 36 months | Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group. |
| Secondary | To assess the pharmacokinetic profile of CFI-400945 through Cmax. | 36 months | Cmax will be assessed through the maximum measured plasma concentration occurring at Tmax tabulated by dose group. |
| Secondary | To assess the pharmacokinetic profile of CFI-400945 through T1/2. | 36 months | Elimination half life will be calculated and tabulated by dose group. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38114624 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04730258
GET https://conductscience.org/api/trials/v1/NCT04730258/registered