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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 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.

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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.

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

Sponsor

Kura Oncology

14 total trials

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What the Registry Record Tells You About NCT04067336

The ClinicalTrials.gov registry entry for NCT04067336 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (129% higher). The listed sponsor is Kura Oncology, which has 14 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.