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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)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement.
  • - For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment.
  • - Measurable or evaluable disease.
  • - Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed.
  • - Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements) - Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression.
Other ALK inhibitors are prohibited.
  • - At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy.
  • - At least 4 weeks must have elapsed since completion of antibody-directed therapy.
  • - Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment.
  • - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks.
  • - Adequate organ function as defined per protocol.
  • - Ability to swallow entrectinib intact.
  • - Other protocol specified criteria.

Exclusion Criteria:

  • - Current participation in another therapeutic clinical trial.
  • - Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements.
  • - Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression.
Other ALK inhibitors are prohibited.
  • - History of other previous cancer that would interfere with the determination of safety or efficacy.
  • - Familial or personal history of congenital bone disorders, or bone metabolism alterations.
  • - Incomplete recovery from any surgery.
  • - History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study.
  • - History of non-pharmacologically induced prolonged QTc interval.
  • - History of additional risk factors for torsades de pointes.
  • - Peripheral neuropathy Grade ≥ 2.
  • - Known active infections.
  • - Active gastrointestinal disease or other malabsorption syndromes.
  • - Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis.
- Other protocol specified criteria

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02568267
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Australia, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Taiwan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Melanoma, Neuroendocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, Primary Brain Tumors, Renal Cell Carcinoma, Sarcomas, Salivary Gland Cancers, Adult Solid Tumor
Arms & Interventions

Arms

Experimental: NTRK1/2/3-rearranged NSCLC

Oral entrectinib (RXDX-101)

Experimental: ROS1-rearranged NSCLC

Oral entrectinib (RXDX-101)

Experimental: ALK- or ROS1-rearranged NSCLC

with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.) Oral entrectinib (RXDX-101)

Experimental: NTRK/1/2/3-rearranged mCRC

Oral entrectinib (RXDX-101)

Experimental: ROS1-rearranged mCRC

Oral entrectinib (RXDX-101)

Experimental: ALK-rearranged mCRC

Oral entrectinib (RXDX-101)

Experimental: NTRK1/2/3-rearranged other solid tumor

Oral entrectinib (RXDX-101)

Experimental: ROS1-rearranged other solid tumor

Oral entrectinib (RXDX-101)

Experimental: ALK-rearranged other solid tumor

Oral entrectinib (RXDX-101)

Interventions

Drug: - Entrectinib

TrkA/B/C, ROS1, and ALK inhibitor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Address

Dignity Health St Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

Mayo Clinic, Scottsdale, Arizona

Status

Address

Mayo Clinic

Scottsdale, Arizona, 85259

Duarte, California

Status

Address

City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics

Duarte, California, 91010

Scripps Clinic, La Jolla, California

Status

Address

Scripps Clinic

La Jolla, California, 92037

La Jolla, California

Status

Address

University of California San Diego Moores Cancer Center; Dept of Lung Cancer

La Jolla, California, 92093

Los Angeles, California

Status

Address

University of Southern California Medical Center

Los Angeles, California, 90033

Orange, California

Status

Address

Univ Of California Irvine College Of Medicine; 300194620

Orange, California, 92868

Southern California Kaiser Permanente, San Diego, California

Status

Address

Southern California Kaiser Permanente

San Diego, California, 92108

UCSF Mount Zion Medical Ctr, San Francisco, California

Status

Address

UCSF Mount Zion Medical Ctr

San Francisco, California, 94115

Sarcoma Oncology Center, Santa Monica, California

Status

Address

Sarcoma Oncology Center

Santa Monica, California, 90403

University of Colorado Cancer Center, Aurora, Colorado

Status

Address

University of Colorado Cancer Center

Aurora, Colorado, 80045

Yale University, New Haven, Connecticut

Status

Address

Yale University

New Haven, Connecticut, 06510

Washington, District of Columbia

Status

Address

Georgetown University Medical Center Lombardi Cancer Center

Washington, District of Columbia, 20007

Florida Cancer Specialists - Sarasota, Sarasota, Florida

Status

Address

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34232

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, 33612

Athens, Georgia

Status

Address

University Cancer & Blood Center, LLC; Research

Athens, Georgia, 30607

Winship Cancer Institute, Atlanta, Georgia

Status

Address

Winship Cancer Institute

Atlanta, Georgia, 30322

Newnan, Georgia

Status

Address

Southeastern Regional Medical Center, Inc.

Newnan, Georgia, 30265

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Park Ridge, Illinois

Status

Address

Advocate Medical Group - Park Ridge, Luther Lane - Oncology

Park Ridge, Illinois, 60068

Midwestern Regional Medical Center, Zion, Illinois

Status

Address

Midwestern Regional Medical Center

Zion, Illinois, 60099

Baltimore, Maryland

Status

Address

Weinberg Cancer Institution at Franklin Square

Baltimore, Maryland, 21237

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Ann Arbor, Michigan

Status

Address

University of Michigan Comprehensive Cancer Center; Clinical Trials Office

Ann Arbor, Michigan, 48109

Karmanos Cancer Center, Detroit, Michigan

Status

Address

Karmanos Cancer Center

Detroit, Michigan, 48201

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Regents of the University of Minnesota, Minneapolis, Minnesota

Status

Address

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455

Washington University, Saint Louis, Missouri

Status

Address

Washington University

Saint Louis, Missouri, 63128

Las Vegas, Nevada

Status

Address

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, 89169

North Shore Hem Onc Associates, East Setauket, New York

Status

Address

North Shore Hem Onc Associates

East Setauket, New York, 11733

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 11101

Levine Cancer Institute, Charlotte, North Carolina

Status

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

Duke Cancer Institute, Durham, North Carolina

Status

Address

Duke Cancer Institute

Durham, North Carolina, 27710

OSU, James Cancer Hospital, Columbus, Ohio

Status

Address

OSU, James Cancer Hospital

Columbus, Ohio, 43210

Tulsa, Oklahoma

Status

Address

Cancer Treatment Centers of America; Tulsa

Tulsa, Oklahoma, 74133

Oregon Health & Science Univ, Portland, Oregon

Status

Address

Oregon Health & Science Univ

Portland, Oregon, 97239

Philadelphia, Pennsylvania

Status

Address

Cancer Treatment Centers of America - Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124

Mary Crowley Medical Research Center, Dallas, Texas

Status

Address

Mary Crowley Medical Research Center

Dallas, Texas, 75230

Houston, Texas

Status

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Baylor Scott & White Health, Temple, Texas

Status

Address

Baylor Scott & White Health

Temple, Texas, 76502

University of Utah Hospitals & Clinics, Salt Lake City, Utah

Status

Address

University of Utah Hospitals & Clinics

Salt Lake City, Utah, 84132

Virginia Cancer Specialists, PC, Fairfax, Virginia

Status

Address

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031

Virginia Oncology Associates - Hampton, Hampton, Virginia

Status

Address

Virginia Oncology Associates - Hampton

Hampton, Virginia, 23666

Seattle, Washington

Status

Address

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, 98195

International Sites

Liverpool Hospital, Liverpool, New South Wales, Australia

Status

Address

Liverpool Hospital

Liverpool, New South Wales, 2170

Newcastle Private Hospital, New Lambton Heights, New South Wales, Australia

Status

Address

Newcastle Private Hospital

New Lambton Heights, New South Wales, 2305

Flinders Medical Centre, Bedford Park, South Australia, Australia

Status

Address

Flinders Medical Centre

Bedford Park, South Australia, 5042

Austin Health, Heidelberg, Victoria, Australia

Status

Address

Austin Health

Heidelberg, Victoria, 3084

Antwerp University Hospital, Edegem, Belgium

Status

Address

Antwerp University Hospital

Edegem, , 2650

Beijing Cancer Hospital, Beijing, China

Status

Address

Beijing Cancer Hospital

Beijing, , 100142

Sichuan Provincial Cancer Hospital, Chengdu, China

Status

Address

Sichuan Provincial Cancer Hospital

Chengdu, , 610041

Guangzhou, China

Status

Address

Cancer Center of Guangzhou Medical University

Guangzhou, , 510000

Harbin, China

Status

Address

Harbin Medical University Cancer Hospital

Harbin, , 150081

Fudan University Shanghai Cancer Center, Shanghai City, China

Status

Address

Fudan University Shanghai Cancer Center

Shanghai City, , 200120

Shanghai chest hospital, Shanghai, China

Status

Address

Shanghai chest hospital

Shanghai, , 200030

Shenzhen People's Hospital, Shenzhen, China

Status

Address

Shenzhen People's Hospital

Shenzhen, , 510852

Tianjin Cancer Hospital, Tianjin, China

Status

Address

Tianjin Cancer Hospital

Tianjin, , 300060

Wuhan City, China

Status

Address

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan City, , 430023

Zhejiang Cancer Hospital, Zhejiang, China

Status

Address

Zhejiang Cancer Hospital

Zhejiang, , 310022

Institut de Cancerologie de l Ouest, Angers, France

Status

Address

Institut de Cancerologie de l Ouest

Angers, , 49055

Institut Bergonie; Oncologie, Bordeaux, France

Status

Address

Institut Bergonie; Oncologie

Bordeaux, , 33076

Lyon, France

Status

Address

Centre Leon Berard; Departement Oncologie Medicale

Lyon, , 69373

Marseille cedex 5, France

Status

Address

Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs

Marseille cedex 5, , 13385

Marseille, France

Status

Address

Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire

Marseille, , 13015

Montpellier cedex 5, France

Status

Address

Institut de Recherche en Cancérologie de Montpellier

Montpellier cedex 5, , 34298

Institut Curie; Oncologie Medicale, Paris, France

Status

Address

Institut Curie; Oncologie Medicale

Paris, , 75231

Saint Herblain, France

Status

Address

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

Saint Herblain, , 44805

Toulouse, France

Status

Address

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, , 31059

Villejuif cedex, France

Status

Address

Institut Gustave Roussy; Pathologie Thoracique

Villejuif cedex, , 94805

Berlin, Germany

Status

Address

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, , 13125

Dresden, Germany

Status

Address

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , 01307

Göttingen, Germany

Status

Address

Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

Göttingen, , 37075

Heidelberg, Germany

Status

Address

NCT Uniklinikum Heidelberg; Medizinische Onkologie

Heidelberg, , 69120

Köln, Germany

Status

Address

Universitaetsklinikum Koeln; Innere Medizin I, Haematologie

Köln, , 50937

Princess Margaret Hospital, Hong Kong, Hong Kong

Status

Address

Princess Margaret Hospital

Hong Kong, ,

The University of Hong Kong, Hong Kong, Hong Kong

Status

Address

The University of Hong Kong

Hong Kong, ,

Queen Elizabeth Hospital, Kowloon, Hong Kong

Status

Address

Queen Elizabeth Hospital

Kowloon, ,

The Chinese University of Hong Kong, Shatin, Hong Kong

Status

Address

The Chinese University of Hong Kong

Shatin, , 123456

Napoli, Campania, Italy

Status

Address

Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia

Napoli, Campania, 80131

Roma, Lazio, Italy

Status

Address

Università Campus Bio-Medico di Roma; Oncologia Medica

Roma, Lazio, 128

Milano, Lombardia, Italy

Status

Address

Fondazione IRCCS Istituto Nazionale dei Tumori

Milano, Lombardia, 20133

Milano, Lombardia, Italy

Status

Address

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

Milano, Lombardia, 20162

Pisa, Toscana, Italy

Status

Address

Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

Pisa, Toscana, 56126

Perugia, Umbria, Italy

Status

Address

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica

Perugia, Umbria, 6132

Padova, Veneto, Italy

Status

Address

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

Padova, Veneto, 35128

Aichi, Japan

Status

Address

Aichi Cancer Center Hospital; Respiratory Medicine

Aichi, , 464-8681

Ehime, Japan

Status

Address

NHO Shikoku Cancer Center; Dept of Respiratory Medicine

Ehime, , 791-0280

NHO Kyushu Cancer Center, Fukuoka, Japan

Status

Address

NHO Kyushu Cancer Center

Fukuoka, , 811-1395

Hyogo, Japan

Status

Address

Hyogo Cancer Center, Dept of Respiratory Medicine

Hyogo, , 673-8558

Kashiwa-shi, Japan

Status

Address

National Cancer Center Hospital; Dept of Respiratory Medicine

Kashiwa-shi, , 277-8577

Miyagi, Japan

Status

Address

Miyagi Cancer Center; Respiratory Medicine

Miyagi, , 981-1293

Niigata, Japan

Status

Address

Niigata Cancer Center Hospital; Internal Medicine

Niigata, , 951-8566

Osaka, Japan

Status

Address

OSAKA CITY GENERAL HOSPITAL;Medical Oncology

Osaka, , 534-0021

Osaka, Japan

Status

Address

Kindai University Hospital; Medical Oncology

Osaka, , 589-8511

Shizuoka, Japan

Status

Address

Shizuoka Cancer Center; Respiratory Internal Medicine

Shizuoka, , 411-8777

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Address

Seoul National University Hospital

Seoul, , 03080

Seoul, Korea, Republic of

Status

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722

Samsung Medical Center, Seoul, Korea, Republic of

Status

Address

Samsung Medical Center

Seoul, , 06351

Asan Medical Center., Seoul, Korea, Republic of

Status

Address

Asan Medical Center.

Seoul, , 5505

NKI The Netherlands Cancer Institute, Amsterdam, Netherlands

Status

Address

NKI The Netherlands Cancer Institute

Amsterdam, , 1066 CX

Leids Universitair Medisch Centrum, Leiden, Netherlands

Status

Address

Leids Universitair Medisch Centrum

Leiden, , 2333 ZA

Gdansk, Poland

Status

Address

Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

Gdansk, , 80-214

Gliwice, Poland

Status

Address

Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology

Gliwice, , 44-101

Pozna?, Poland

Status

Address

Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

Pozna?, , 60-569

Warszawa, Poland

Status

Address

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

Warszawa, , 02-781

Singapore, Singapore

Status

Address

National University Hospital; Haematology/Oncology

Singapore, , 119074

National Cancer Centre, Singapore, Singapore

Status

Address

National Cancer Centre

Singapore, , 169610

Fuenlabrada, Madrid, Spain

Status

Address

Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit

Fuenlabrada, Madrid, 28942

Barcelona, Spain

Status

Address

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

Barcelona, , 08035

Madrid, Spain

Status

Address

Hospital Universitario Ramon y Cajal; Servicio de Farmacia

Madrid, , 28034

Madrid, Spain

Status

Address

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, , 28040

Madrid, Spain

Status

Address

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , 28041

Madrid, Spain

Status

Address

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , 28046

Malaga, Spain

Status

Address

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Malaga, , 29010

Sevilla, Spain

Status

Address

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, , 41013

National Cheng Kung University Hospital, Tainan, Taiwan

Status

Address

National Cheng Kung University Hospital

Tainan, , 70457

Taipei Veterans General Hospital, Taipei City, Taiwan

Status

Address

Taipei Veterans General Hospital

Taipei City, , 11217

National Taiwan University Hospital, Taipei, Taiwan

Status

Address

National Taiwan University Hospital

Taipei, , 10002

Addenbrookes Hospital, Cambridge, United Kingdom

Status

Address

Addenbrookes Hospital

Cambridge, , CB2 0QQ

Sarah Cannon Research Institute, London, United Kingdom

Status

Address

Sarah Cannon Research Institute

London, , W1G 6AD

Manchester, United Kingdom

Status

Address

Christie Hospital Nhs Trust; Medical Oncology

Manchester, , M2O 4BX