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NCT04067336 · ClinicalTrials.gov registry record · Phase 1

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

A Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Kura Oncology.

Recruiting
Registry status
Phase 1
Development phase
263
Enrollment target
20
Study locations

NCT04067336: Recruiting Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Kura Oncology.

NCT04067336 is a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Kura Oncology. The registered enrollment target is 263 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (129% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04067336, a Phase 1 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Kura Oncology.

RECRUITING
Registry status
Phase 1
Development phase
263 participants
Enrollment target
20
Study locations

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.

Primary Outcome

MTD is defined as the highest dose that is not expected to cause dose limiting toxicity (DLT) in more than 20% of patients.

Conditions Studied

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia Advanced Malignant Neoplasm Acute Leukemia of Ambiguous Lineage Mixed Lineage Leukemia Mixed Lineage Acute Leukemia

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

FieldValue
Enrollment Target 263 participants
Start Date 2019-09-12
Est. Completion 2028-10-16
Phase Phase 1
Kura Oncology

14 total trials

What NCT04067336 shows while recruiting

NCT04067336 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (129% higher).

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.

NCT04067336 names 20 study sites across 15 states, led by New York, Arizona, California.

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.

What interventions are being tested in trial NCT04067336?

The interventions under investigation include: Midazolam (DRUG), Itraconazole (DRUG), Ziftomenib (DRUG).

Who is sponsoring clinical trial NCT04067336?

This trial is sponsored by Kura Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04067336's enrollment target sits among peer trials

263 32nd of 306 higher than 275 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04067336

Source: ClinicalTrials.gov NCT04067336, the US trial registry maintained by the National Library of Medicine. NCT04067336 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.