Trial · NCT05735184
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
NCT05735184, Phase 1, Recruiting, Kura Oncology, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML. Trials, record NCT05735184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05735184
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
- NCT number
- NCT05735184
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 420 participants, estimated
- Lead sponsor
- Kura Oncology, Inc.
- Conditions
Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1, Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, in Relapse, NPM1 Mutation, KMT2Ar, Myeloid Sarcoma, Nucleophosmin 1-mutated Acute Myeloid Leukemia
- Interventions
- Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine, Quizartinib
- First posted
- 2023-02-21
- Last updated
- 2026-03-13
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only) | During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle) | Assessed by the NCI-CTCAE v5.0 |
| Primary | Descriptive statistics of adverse events | From Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment | Assessed by the NCI-CTCAE v5.0 |
| Primary | Complete remission (CR) rate | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first | Assessed by the ELN 2022 criteria |
| Secondary | Composite Complete Remission (CRc) | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first | Assessed by the ELN 2022 criteria |
| Secondary | Morphologic leukemia-free state (MLFS) rate | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever comes first | Assessed by the ELN 2022 criteria |
| Secondary | Measurable residual disease (MRD) | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first | Assessed by multiparameter flow cytometry (MFC) and/or molecular analysis (NGS, PCR) |
| Secondary | Median OS | From Cycle 1 Day 1 to date of death from any cause, assessed up to 36 months of treatment | To assess overall survival of ziftomenib |
| Secondary | Proportion of patients alive | From Cycle 1 Day 1 until death from any cause, assessed up to 1 year following start of treatment | To assess proportion of patients alive at 1 year following start of treatment with ziftomenib |
| Secondary | Median EFS | From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months of treatment | To assess median event free survival |
| Secondary | EFS | From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 1 year following start of treatment | To assess event free survival at 1 year |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
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 |
|---|---|
| 42227701 | 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/NCT05735184
GET https://conductscience.org/api/trials/v1/NCT05735184/registered?page=2