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ACTIVE NOT RECRUITING
NCT02568267
PHASE2

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Official title: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

534

Start Date

2015-11-19

Completion Date

2026-05-14

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

Entrectinib

TrkA/B/C, ROS1, and ALK inhibitor

Locations (130)

Dignity Health St Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

City of Hope Cancer Center

Duarte, California, United States

City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services

Duarte, California, United States

Scripps Clinic

La Jolla, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Southern California Kaiser Permanente

Los Angeles, California, United States

University of Southern California Medical Center

Los Angeles, California, United States

Univ Of California Irvine College Of Medicine

Orange, California, United States

UCSF Mount Zion Medical Ctr

San Francisco, California, United States

UCSF Mission Bay

San Francisco, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

Sarcoma Oncology Research Center LLC

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Southeastern Regional Medical Center, Inc.

Newnan, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Advocate Medical Group - Park Ridge, Luther Lane - Oncology

Park Ridge, Illinois, United States

Midwestern Regional Medical Center

Zion, Illinois, United States

Weinberg Cancer Institution at Franklin Square

Baltimore, Maryland, United States

Massachusetts General Hosp CAR

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Regents of the University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, United States

North Shore Hem Onc Associates

East Setauket, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

OSU, James Cancer Hospital

Columbus, Ohio, United States

Cancer Treatment Centers of America

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Oregon Health & Science Univ

Portland, Oregon, United States

Mary Crowley Medical Research Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Baylor Scott & White Health

Temple, Texas, United States

University of Utah Hospitals & Clinics

Salt Lake City, Utah, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Virginia Oncology Associates - Hampton

Norfolk, Virginia, United States

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States

Liverpool Hospital

Liverpool, New South Wales, Australia

Newcastle Private Hospital

Newcastle, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Pharmacy

Edegem, Belgium

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Beijing Cancer Hospital

Beijing, China

Cancer Center of Guangzhou Medical University

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Shanghai chest hospital

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shenzhen People's Hospital

Shenzhen, China

Institut de Cancerologie de l Ouest

Angers, France

Institut Bergonie

Bordeaux, France

Centre Leon Berard

Lyon, France

Hôpital de la Timone

Marseille, France

Hôpital Nord - AP-HM Marseille#

Marseille, France

Institut de Recherche en Cancérologie de Montpellier

Montpellier, France

Institut Curie

Paris, France

Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology

Saint-Herblain, France

Institut Claudius Regaud

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Universitaetsmedizin Goettingen

Göttingen, Germany

NCT Uniklinikum Heidelberg

Heidelberg, Germany

Princess Margaret Hospital

Hong Kong, Hong Kong

The University of Hong Kong

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Kowloon, Hong Kong

The Chinese University of Hong Kong

Shatin, Hong Kong

Seconda Università degli Studi di Napoli

Naples, Campania, Italy

Università Campus Bio-Medico di Roma

Rome, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

Perugia, Umbria, Italy

IOV - Istituto Oncologico Veneto - IRCCS

Padova, Veneto, Italy

Aichi Cancer Center Hospital

Aichi, Japan

National Cancer Center Hospital

Chūō, Japan

NHO Kyushu Cancer Center

Fukuoka, Japan

Hyogo Cancer Center, Dept of Respiratory Medicine

Hyōgo, Japan

National Cancer Center Hospital

Kashiwa-shi, Japan

NHO Shikoku Cancer Center

Matsuyama, Japan

Miyagi Cancer Center

Miyagi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka City General Hospital

Osaka, Japan

Kindai University Hospital

Osaka, Japan

Shizuoka Cancer Center

Shizuoka, Japan

NKI The Netherlands Cancer Institute

Amsterdam, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

Gliwice, Poland

Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego

Późna, Poland

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

Warsaw, Poland

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center.

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Centro Nacional de Investigaciones Oncológicas(CNIO)

Fuenlabrada, Madrid, Spain

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Addenbrookes Hospital

Cambridge, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

The Christie

Manchester, United Kingdom