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Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Sponsor: Kartos Therapeutics, Inc.
Summary
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
Official title: A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2024-06-03
Completion Date
2028-12-31
Last Updated
2025-09-25
Healthy Volunteers
No
Interventions
Navtemadlin
Navtemadlin is an investigational MDM2 inhibitor
Navtemadlin placebo
Navtemadlin placebo
Ruxolitinib
Ruxolitinib is a janus kinase 1/2 inhibitor
Locations (215)
UAB Hospital
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UCLA Hematology/Oncology Clinic - Los Angeles
Los Angeles, California, United States
Scripps Health, Prebys Cancer Center
San Diego, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mission Cancer + Blood
Des Moines, Iowa, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska, United States
Mohtaseb Cancer Center and Blood Disorders
Henderson, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States
Cayuga Cancer Center
Ithaca, New York, United States
Northwell Health, R.J. Zuckerberg Cancer Center
Lake Success, New York, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Medical University of South Carolina (MUSC)
Charleston, North Carolina, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Independence Family Health Center - Cleveland Clinic
Independence, Ohio, United States
Hillcrest Hospital - Cleveland Clinic
Mayfield Heights, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT - SouthWestern
Dallas, Texas, United States
U.T. MD Anderson Cancer Center
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Institute
Richmond, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, United States
Fred Hutchinson Cancer Centre
Seattle, Washington, United States
Northwest Medical Specialties, PLLC - Tacoma
Tacoma, Washington, United States
Sheboygan Cancer & Blood Specialists
Sheboygan, Wisconsin, United States
Royal Hobart Hospital (RHH)
Hobart, Tasmania, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, Australia
Monash Medical Center Clayton
Clayton, Australia
Townsville University Hospital
Douglas, Australia
Gosford Hospital
Gosford, Australia
St George Hospital
Kogarah, Australia
The Royal Melbourne Hospital - Peter MacCallum Cancer Center
Melbourne, Australia
The Alfred Hospital
Melbourne, Australia
Royal Perth Hospital
Perth, Australia
Calvary Mater Newcastle Hospital
Waratah, Australia
University Hospital Graz, Department of Internal Medicine
Graz, Austria
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
Innsbruck, Austria
Regional Hospital Hochsteiermark - Leoben, Department of Internal Medicine, Department of Hematology and Oncology
Leoben, Austria
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Internal Medicine I - Hemato-Oncology
Linz, Austria
Kepler University Hospital GmbH, Med Campus 3, University Clinic for Hematology and Internal Oncology
Linz, Austria
Medical University Vienna
Vienna, Austria
Hospital Ottakring, Department of Internal Medicine I
Vienna, Austria
Antwerp Hospital Network (ZNA) Cadix
Antwerp, Belgium
University Hospitals Leuven, Campus Gasthuisberg
Leuven, Belgium
University Hospital Center Sart-Tilman
Liège, Belgium
General Hospital Delta
Roeselare, Belgium
UCL Mont-Godinne University Hospitals
Yvoir, Belgium
Clinical Hospital Centre Rijeka
Rijeka, Croatia
University Hospital of Split
Split, Croatia
General Hospital of Sibenik-Knin County
Šibenik, Croatia
Clinical Hospital Dubrava
Zagreb, Croatia
Clinical Hospital Merkur
Zagreb, Croatia
Solmed Clinic
Zagreb, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, Czechia
University Hospital Hradec Kralove
Hradec Králové, Czechia
University Hospital Ostrava
Ostrava, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Institute of Hematology and Blood Transfusion
Prague, Czechia
Saint-Louis Hospital, Department of Adult Hematology
Paris, Paris, France
Amiens Picardie University Hospital - South
Amiens, France
Angers University Hospital Center
Angers, France
Lille Regional University Hospital Center
Lille, France
South Lyon Hospital Center
Lyon, France
Leon Berard Center
Lyon, France
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, France