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RECRUITING
NCT06479135
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

Navtemadlin

Navtemadlin is an investigational MDM2 inhibitor

DRUG

Navtemadlin placebo

Navtemadlin placebo

DRUG

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

Archet 1 and 2 hospital

Nice, France

Nimes University Hospital Center, Department of Clinical Hematology and Medical Oncology

Nîmes, France

Bordeaux University Hospital

Pessac, France

University Hospital Center of Poitiers

Poitiers, France

Strasbourg Europe Institut of Cancerology

Strasbourg, France

University Hospital of Toulouse, IUCT-Oncopole

Toulouse, France

Tours Regional University Hospital Center

Tours, France

JSC Vian

Kutaisi, Georgia

JSC German Hospital

Tbilisi, Georgia

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

Tbilisi, Georgia

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia

Caucasus Medical Centre LLC

Tbilisi, Georgia

Marien Hospital Duesseldorf GmbH

Düsseldorf, Germany

University Hospital Freiburg

Freiburg im Breisgau, Germany

University Hospital Halle (Saale)

Halle, Germany

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Hannover Medical School

Hanover, Germany

University Hospital Heidelberg

Heidelberg, Germany

University Hospital Jena

Jena, Germany

University Hospital Schleswig-Holstein

Kiel, Germany

MVZ Mitte Am Johannisplatz

Leipzig, Germany

Hospital Rechts der Isar

Munich, Germany

Staufer Schwaebisch Gmuend Hospital

Mutlangen, Germany

Hospital Nuernberg, Campus North

Nuremberg, Germany

Robert-Bosch-Hospital

Stuttgart, Germany

University Hospital Ulm

Ulm, Germany

General Hospital of Athens Laikon

Athens, Greece

University General Hospital "Attikon"

Athens, Greece

University General Hospital of Ioannina

Ioannina, Greece

University General Hospital of Patras

Pátrai, Greece

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, Greece

Semmelweis University

Budapest, Hungary

Szabolcs-Szatmar-Bereg County Teaching Hospital

Nyíregyháza, Hungary

Tolna County Hospital

Szekszárd, Hungary

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, Hungary

National Hospital SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Marche University Hospital

Ancona, Italy

Polyclinic S. Orsola-Malpighi

Bologna, Italy

ASST Spedali Civili Brescia

Brescia, Italy

University Hospital "G.Rodolico - San Marco"

Catania, Italy

Careggi University Hospital

Florence, Italy

Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST

Forlì, Italy

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

Milan, Italy

European Institute of Oncology (IEO), IRCCS

Milan, Italy

University Hospital "Maggiore della Carita" of Novara

Novara, Italy

University Hospital San Luigi Gonzaga

Orbassano, Italy

University Polyclinic Hospital "Paolo Giaccone" Palermo

Palermo, Italy

Polyclinic San Matteo, IRCCS

Pavia, Italy

Local Health Company of Pesaro and Urbino

Pesaro, Italy

Hospital Arcispedale S. Maria Nuova of Reggio Emilia

Reggio Emilia, Italy

Hospital S. Eugenio- Rome 2 ASL

Rome, Italy

City of Health and Science of Turin

Turin, Italy

ASST Sette Laghi Hospital

Varese, Italy

"InterHem" General Partnership

Bialystok, Poland

University Teaching Centre, Hematology and Transplantology Clinic

Gdansk, Poland

Independent Public Healthcare Facility University Hospital in Krakow

Krakow, Poland

Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center

Lodz, Poland

Jedrzej Sniadecki Specialist Hospital in Nowy Sacz

Nowy Sącz, Poland

Oncology Center of Warmia and Mazury in Olsztyn

Olsztyn, Poland

AIDPORT

Poznan, Poland

Dom Lekarski Medical Center Outlet Park

Szczecin, Poland

Janusz Korczak Provincial Specialist Hospital

Słupsk, Poland

Clinical Best Solutions LLC, Limited Partnership

Warsaw, Poland

Dr Alfred Sokolowski Specialty Hospital

Wałbrzych, Poland

Jan Mikulicz-Radecki Teaching Hospital in Wroclaw

Wroclaw, Poland

Hospital Center of Baixo Vouga -Aveiro Unit - Hospital Infante D. Pedro

Aveiro, Portugal

Braga Hospital

Braga, Portugal

Central Hospital of Western Lisbon

Lisbon, Portugal

Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria

Lisbon, Portugal

Vila Nova de Gaia Central Hospital

Vila Nova de Gaia, Portugal

Onco Card Srl

Brasov, Romania

Colentina Clinical Hospital, Department of Hematology

Bucharest, Romania

"Prof. Dr. Ion Chiricuta" Institute of Oncology, Hematology Department

Cluj-Napoca, Romania

Bihor County Emergency Clinical Hospital, Department of Hematology

Oradea, Romania

Targu Mures County Emergency Clinical Hospital, Internal Medicine Department I, Hematology Unit

Târgu Mureş, Romania

University Clinical Center of Serbia

Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Clinical Center of Vojvodina

Novi Sad, Serbia

Inje University Busan Paik Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Keimyung University - Dongsan Medical Center

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

University Hospital Germans Trias i Pujol

Badalona, Spain

University Hospital Vall d'Hebron

Barcelona, Spain

Catalan Institute of Oncology, Hospital Duran i Reynals

Barcelona, Spain

Caceres Hospital Complex - San Pedro de Alcantara General Hospital

Cáceres, Spain

Gran Canaria Dr Negrin University Hospital

Las Palmas de Gran Canaria, Spain

University Hospital 12 de Octubre

Madrid, Spain

University Hospital Ramon y Cajal

Madrid, Spain

University Hospital Virgen de la Victoria

Málaga, Spain

University Clinical Hospital of Salamanca

Salamanca, Spain

University Clinical Hospital of Valencia

Valencia, Spain

University and Polytechnic Hospital La Fe

Valencia, Spain

Quironsalud Zaragoza Hospital

Zaragoza, Spain

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Lincoln County Hospital

Boston, United Kingdom

Pilgrim Hospital

Boston, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Western General Hospital, Lothian Health Board

Edinburgh, United Kingdom

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Harrogate District Hospital

Harrogate, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

The Clatterbridge Cancer Center NHS Foundation Trust

Liverpool, United Kingdom

University College Hospital

London, United Kingdom

Guy's Hospital

London, United Kingdom

Genesis Care, Oxford

Oxford, United Kingdom

Genesis Care, Windsor

Windsor, United Kingdom