Spots Global Cancer Trial Database for First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
Official Title: 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
Study ID: NCT04067336
Interventions
Study Description
Brief Summary: This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML.
Detailed Description: This Phase 1/2, first-in-human (FIH), open-label, dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML). The dose-escalation part of the study (Phase 1a) will determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D). The dose-validation/expansion part of the study (Phase 1b) will determine the safety, tolerability, and minimal biologically effective dose of ziftomenib in dosing cohorts which have demonstrated early biological activity and have been determined to be safe in the dose-escalation phase. The Phase 2 portion of the study will determine the safety, tolerability, and anti-leukemia activity of ziftomenib in patients with NPM1-m AML.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Bowyer Oncology Center, Los Angeles, California, United States
Mayo Clinic, Jacksonville, Florida, United States
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
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
Hopital Maisonneuve-Rosemont, Montréal, Quebec, Canada
Hopital de l'Enfant-Jesus - Centre Integre en Cancerologie du CHU de Quebec - Universite Laval, Québec, Quebec, Canada
CHU de Quebec - Universite Laval, Hopital de l'Enfant - Jesus, Québec, Quebec, Canada
CHU de Lille, Lille, , France
CHU 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, Hannover, , 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
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, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St. George's Hospital, London, , United Kingdom
Contact Details
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