RecruitingPhase 1Phase 2NCT04176198

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis

Sponsor

Sumitomo Pharma America, Inc.

Enrollment

240 participants

Start Date

Dec 16, 2019

Study Type

INTERVENTIONAL

Conditions

Myelofibrosis

Summary

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Momelotinib, a drug called Nusivertib, and others for people with myelofibrosis. The study is currently recruiting participants at 84 locations. People eligible for this study include aged 18 Years and older.

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

DRUGNusivertib

Oral PIM Inhibitor

DRUGRuxolitinib

Oral JAK inhibitor

DRUGMomelotinib

Oral JAK inhibitor

Locations(84)

University of Alabama

Birmingham, Alabama, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

University of Southern California

Los Angeles, California, United States

Hoag Family Cancer Institute

Newport Beach, California, United States

Blood Cancer Center

Denver, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

University of Florida Health Shands Cancer Hospital

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Health - Miami Cancer Institute

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Montefiore Cancer Center

The Bronx, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Tri-Star Centennial Medical Center

Nashville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

University of Washington - Fred Hutchinson Cancer Center

Seattle, Washington, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Eastern Health Box Hill Hospital

Box Hill, Victoria, Australia

Monash University

Clayton, Victoria, Australia

Peter McCallum Center

Melbourne, Victoria, Australia

Epworth Healthcare

Richmond, Victoria, Australia

Icon Cancer Centre (Ashford Cancer Centre Research)

Adelaide, Australia

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

ZNA Cadix

Antwerp, Belgium

ZNA Middelheim

Antwerp, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

CHU de Liege

Liège, Belgium

University of Calgary

Calgary, Alberta, Canada

St. Paul's Hospital Hematology/Oncology Research

Vancouver, British Columbia, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Juravinski Cancer Center

Hamilton, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire D'Amiens

Amiens, France

CHU Angers

Angers, France

Centre Hospitalier Lyon Sud

Lyon, France

Hospitalier Universitaire (CHU) de Nice - Hopital de l'Archet

Nice, France

Institut de cancerologie du Gard

Nîmes, France

Institut de cancerologie du Gard

Nîmes, France

Hospital Saint Louis

Paris, France

University Hospital of Poitiers

Poitiers, France

Institut Gustave Roussy

Villejuif, France

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Istituto Nazionale Tumori, IRCCS Centro di Riferimento Oncologico di Aviano

Aviano, Italy

IRCCS Azienda Ospedaliero -Universitaria Di Bologna - Dipartimento Malattie Oncologiche ed Ematologiche - UO Ematologia

Bologna, Italy

ASST - Spedali Civili di Brescia

Brescia, Italy

IRCCS istituto Romagnolo per lo studio dei tumori "Dino Amadori"

Meldola, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Azienda Ospedaliera Universitaria Citta' Della Salute E della Scienza di Torino

Torino, Italy

Aichi Medical University Hospital

Aichi, Japan

Aomori Prefectural Central Hospital

Aomori, Japan

National Cancer Center Hospital East

Chiba, Japan

Kyushu University Hospital

Fukuoka, Japan

Hokkaido University Hospital

Hokkaido, Japan

Shonan Kamakura General Hospital

Kamakura, Japan

University of Miyazaki Hospital

Miyazaki, Japan

Okayama University Hospital

Okayama, Japan

The University of Osaka Hospital

Osaka, Japan

Saitama Medical Center

Saitama, Japan

Tohoku University Hospital

Sendai, Japan

Shizuoka Cancer Center

Shizuoka, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Juntendo University Hospital

Tokyo, Japan

Mie University Hospital

Tsu, Japan

Lincoln County Hospital

Lincoln, United Kingdom

United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital

Lincoln, United Kingdom

University College London Hospital's NHS foundation Trust

London, United Kingdom

Oxford University Hospitals NHS Foundation

Oxford, United Kingdom

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