Breast Cancer Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

700

Study ID:

NCT02568267

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 119 Locations for this study

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Dignity Health St Joseph's Hospital and Medical Center
Phoenix Arizona, 85013, United States
Mayo Clinic
Scottsdale Arizona, 85259, United States
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
Duarte California, 91010, United States
Scripps Clinic
La Jolla California, 92037, United States
University of California San Diego Moores Cancer Center; Dept of Lung Cancer
La Jolla California, 92093, United States
University of Southern California Medical Center
Los Angeles California, 90033, United States
Univ Of California Irvine College Of Medicine; 300194620
Orange California, 92868, United States
Southern California Kaiser Permanente
San Diego California, 92108, United States
UCSF Mount Zion Medical Ctr
San Francisco California, 94115, United States
Sarcoma Oncology Center
Santa Monica California, 90403, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Yale University
New Haven Connecticut, 06510, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Florida Cancer Specialists - Sarasota
Sarasota Florida, 34232, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa Florida, 33612, United States
University Cancer & Blood Center, LLC; Research
Athens Georgia, 30607, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
Southeastern Regional Medical Center, Inc.
Newnan Georgia, 30265, United States
Northwestern University
Chicago Illinois, 60611, United States
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge Illinois, 60068, United States
Midwestern Regional Medical Center
Zion Illinois, 60099, United States
Weinberg Cancer Institution at Franklin Square
Baltimore Maryland, 21237, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center; Clinical Trials Office
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Center
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Regents of the University of Minnesota
Minneapolis Minnesota, 55455, United States
Washington University
Saint Louis Missouri, 63128, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas Nevada, 89169, United States
North Shore Hem Onc Associates
East Setauket New York, 11733, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke Cancer Institute
Durham North Carolina, 27710, United States
OSU, James Cancer Hospital
Columbus Ohio, 43210, United States
Cancer Treatment Centers of America; Tulsa
Tulsa Oklahoma, 74133, United States
Oregon Health & Science Univ
Portland Oregon, 97239, United States
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia Pennsylvania, 19124, United States
Mary Crowley Medical Research Center
Dallas Texas, 75230, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Baylor Scott & White Health
Temple Texas, 76502, United States
University of Utah Hospitals & Clinics
Salt Lake City Utah, 84132, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates - Hampton
Hampton Virginia, 23666, United States
University of Washington Seattle Cancer Care Alliance
Seattle Washington, 98195, United States
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
Newcastle Private Hospital
New Lambton Heights New South Wales, 2305, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Antwerp University Hospital
Edegem , 2650, Belgium
Beijing Cancer Hospital
Beijing , 10014, China
Sichuan Provincial Cancer Hospital
Chengdu , 61004, China
Cancer Center of Guangzhou Medical University
Guangzhou , 51000, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Shanghai chest hospital
Shanghai , 20003, China
Shenzhen People's Hospital
Shenzhen , 51085, China
Tianjin Cancer Hospital
Tianjin , 30006, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City , 43002, China
Zhejiang Cancer Hospital
Zhejiang , 31002, China
Institut de Cancerologie de l Ouest
Angers , 49055, France
Institut Bergonie; Oncologie
Bordeaux , 33076, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs
Marseille cedex 5 , 13385, France
Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire
Marseille , 13015, France
Institut de Recherche en Cancérologie de Montpellier
Montpellier cedex 5 , 34298, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
Saint Herblain , 44805, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse , 31059, France
Institut Gustave Roussy; Pathologie Thoracique
Villejuif cedex , 94805, France
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin , 13125, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden , 01307, Germany
Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
Göttingen , 37075, Germany
NCT Uniklinikum Heidelberg; Medizinische Onkologie
Heidelberg , 69120, Germany
Universitaetsklinikum Koeln; Innere Medizin I, Haematologie
Köln , 50937, 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 , 12345, Hong Kong
Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia
Napoli Campania, 80131, Italy
Università Campus Bio-Medico di Roma; Oncologia Medica
Roma Lazio, 128, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, 20133, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
Milano Lombardia, 20162, Italy
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
Pisa Toscana, 56126, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica
Perugia Umbria, 6132, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi , 464-8, Japan
NHO Shikoku Cancer Center; Dept of Respiratory Medicine
Ehime , 791-0, Japan
NHO Kyushu Cancer Center
Fukuoka , 811-1, Japan
Hyogo Cancer Center, Dept of Respiratory Medicine
Hyogo , 673-8, Japan
National Cancer Center Hospital; Dept of Respiratory Medicine
Kashiwa-shi , 277-8, Japan
Miyagi Cancer Center; Respiratory Medicine
Miyagi , 981-1, Japan
Niigata Cancer Center Hospital; Internal Medicine
Niigata , 951-8, Japan
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
Osaka , 534-0, Japan
Kindai University Hospital; Medical Oncology
Osaka , 589-8, Japan
Shizuoka Cancer Center; Respiratory Internal Medicine
Shizuoka , 411-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Asan Medical Center.
Seoul , 138-7, Korea, Republic of
NKI The Netherlands Cancer Institute
Amsterdam , 1066 , Netherlands
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk , 80-21, Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology
Gliwice , 44-10, Poland
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy
Poznań , 60-56, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warszawa , 02-78, Poland
National University Hospital; Haematology/Oncology
Singapore , 11907, Singapore
National Cancer Centre
Singapore , 16961, Singapore
Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit
Fuenlabrada Madrid, 28942, Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital Universitario Ramon y Cajal; Servicio de Farmacia
Madrid , 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
National Cheng Kung University Hospital
Tainan , 70457, Taiwan
Taipei Veterans General Hospital
Taipei City , 11217, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

700

Study ID:

NCT02568267

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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