Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
NCT04067336 · View on ClinicalTrials.gov ↗
Study Summary
In this trial, ziftomenib, a menin-MLL(KMT2A) inhibitor, will be tested in patients for the first time. The trial includes a Main Study and four sub-studies. In the Main Study (including Phase 1a, Phase 1b, and Phase 2 portions), ziftomenib will be evaluated in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). The main study has completed enrollment. In Sub-studies 1 and 2, the effects of taking ziftomenib and other common drugs at the same time will be investigated in AML patients. In Sub-study 3, ziftomenib will be evaluated in patients with R/R acute lymphoblastic leukemia (ALL). In Sub-study 4, ziftomenib will be evaluated in patients with R/R AML with certain genetic mutations.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Itraconazole
- DRUG Ziftomenib
Study Locations (20)
New York
- Roswell Park Comprehensive Cancer Center — Buffalo
- Weill Cornell Medical College - NY Presbyterian Hospital — New York
- The Mount Sinai Hospital — New York
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Mayo Clinic — Phoenix
California
- University of Southern California — Los Angeles
- UCLA Ronald Reagan Medical Center — Los Angeles
Michigan
- University of Michigan Hospitals — Ann Arbor
- Karmanos Cancer Institute — Detroit
Florida
- Mayo Clinic — Jacksonville
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2028-10-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04067336
The ClinicalTrials.gov registry entry for NCT04067336 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kura Oncology, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Midazolam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04067336 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04067336 about?
NCT04067336 is a clinical study titled "First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia". In this trial, ziftomenib, a menin-MLL(KMT2A) inhibitor, will be tested in patients for the first time. The trial includes a Main Study and four sub-studies. In the Main Study (including Phase 1a, Phase 1b, and Phase 2 portions), ziftomenib will be evaluated in patients with relapsed or refractory (...
What is the current status of trial NCT04067336?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 263 participants. The study started on 2019-09-12. Estimated completion is 2028-10-16.
What conditions does trial NCT04067336 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia, Advanced Malignant Neoplasm, Acute Leukemia of Ambiguous Lineage. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04067336?
The interventions under investigation include: Midazolam (DRUG), Itraconazole (DRUG), Ziftomenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04067336?
This trial is sponsored by Kura Oncology, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04067336 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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