RecruitingPhase 1Phase 2NCT04067336

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

A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Sponsor

Kura Oncology, Inc.

Enrollment

263 participants

Start Date

Sep 12, 2019

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ziftomenib in people with relapsed or refractory acute myeloid leukemia (AML) — a type of blood cancer that has come back or stopped responding to treatment. The drug targets specific genetic mutations (KMT2A rearrangement or NPM1 mutation) that drive cancer growth. **You may be eligible if...** - You have been diagnosed with AML that has relapsed or is not responding to treatment (5% or more blasts in bone marrow) - Your leukemia has a KMT2A rearrangement or NPM1 mutation (or in sub-studies, related mutations) - You have tried or are not eligible for standard treatments including stem cell transplant **You may NOT be eligible if...** - You do not have one of the specific genetic mutations the study targets - You still have access to approved standard therapies that could work for you - You do not meet the specific health criteria for each study phase Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZiftomenib

Oral administration

DRUGMidazolam

Oral administration

DRUGItraconazole

Oral administration

Locations(56)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

University of Southern California

Los Angeles, California, United States

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Hospitals

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Weill Cornell Medical College - NY Presbyterian Hospital

New York, New York, United States

The Mount Sinai Hospital

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Oklahoma University Health - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Harold C. Simmons Comprehensive Cancer Center - UT Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

UZ Brussel

Jette, Belgium

AZ Delta - Campus Rumbeke

Roeselare, Belgium

CHU UCL Namur

Yvoir, Belgium

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

McMaster University Juravinski Cancer Centre

Hamilton, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Hopital de l'Enfant-Jesus - Centre Integre en Cancerologie du CHU de Quebec - Universite Laval

Québec, Quebec, Canada

Centre Hospitalier Universitaire de Lille

Lille, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

Hopital Saint Louis

Paris, France

Magendie Hopital Haut-Leveque

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Institut Gustave Roussy

Villejuif, France

Charitè-Campus Benjamin Franklin

Berlin, Germany

University Medicine Greifswald

Greifswald, Germany

Medizinische Hochsschule Hannover

Hanover, Germany

Johannes Gutenberg - University Mainz

Mainz, Germany

Institute of Hematology and Medical Oncology "L. and A. Seragnoli"

Bologna, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, Italy

UO Ematologia Ospedale di Ravenna

Ravenna, Italy

Institution Fondazione Policlinico Tor Vergata

Roma, Italy

Nasz Lekarz Przychodnie Medyczne

Torun, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Universitat de Barcelona

Barcelona, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Cardiff and Vale University

Cardiff, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Barts Health NHS Trust

London, United Kingdom

St. George's Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04067336

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