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

Who is this study for? Patients with Solid Tumors
What treatments are being studied? Entrectinib
Status: Active, not recruiting
Location: See all (123) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ 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

Locations
United States
Arizona
Dignity Health St Joseph's Hospital and Medical Center
Phoenix
Mayo Clinic
Scottsdale
California
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
Duarte
Scripps Clinic
La Jolla
University of California San Diego Moores Cancer Center; Dept of Lung Cancer
La Jolla
University of Southern California Medical Center
Los Angeles
Univ Of California Irvine College Of Medicine; 300194620
Orange
Southern California Kaiser Permanente
San Diego
UCSF Mount Zion Medical Ctr
San Francisco
Sarcoma Oncology Center
Santa Monica
Colorado
University of Colorado Cancer Center
Aurora
Connecticut
Yale University
New Haven
Washington, D.c.
Georgetown University Medical Center Lombardi Cancer Center
Washington
Florida
Florida Cancer Specialists - Sarasota
Sarasota
H. Lee Moffitt Cancer Center and Research Inst.
Tampa
Georgia
University Cancer & Blood Center, LLC; Research
Athens
Winship Cancer Institute
Atlanta
Southeastern Regional Medical Center, Inc.
Newnan
Illinois
Northwestern University
Chicago
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge
Midwestern Regional Medical Center
Zion
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Dana Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Maryland
Weinberg Cancer Institution at Franklin Square
Baltimore
Michigan
University of Michigan Comprehensive Cancer Center; Clinical Trials Office
Ann Arbor
Henry Ford Hospital
Detroit
Karmanos Cancer Center
Detroit
Minnesota
Regents of the University of Minnesota
Minneapolis
Missouri
Washington University
Saint Louis
North Carolina
Levine Cancer Institute
Charlotte
Duke Cancer Institute
Durham
Nevada
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas
New York
North Shore Hem Onc Associates
East Setauket
Memorial Sloan Kettering Cancer Center
New York
Ohio
OSU, James Cancer Hospital
Columbus
Oklahoma
Cancer Treatment Centers of America; Tulsa
Tulsa
Oregon
Oregon Health & Science Univ
Portland
Pennsylvania
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia
Texas
Mary Crowley Medical Research Center
Dallas
University of Texas MD Anderson Cancer Center
Houston
Baylor Scott & White Health
Temple
Utah
University of Utah Hospitals & Clinics
Salt Lake City
Virginia
Virginia Cancer Specialists, PC
Fairfax
Virginia Oncology Associates - Hampton
Hampton
Washington
University of Washington Seattle Cancer Care Alliance
Seattle
Other Locations
Australia
Flinders Medical Centre
Bedford Park
Austin Health
Heidelberg
Liverpool Hospital
Liverpool
Newcastle Private Hospital
New Lambton Heights
Belgium
Antwerp University Hospital
Edegem
China
Beijing Cancer Hospital
Beijing
Sichuan Provincial Cancer Hospital
Chengdu
Cancer Center of Guangzhou Medical University
Guangzhou
Harbin Medical University Cancer Hospital
Harbin
Shanghai chest hospital
Shanghai
Fudan University Shanghai Cancer Center
Shanghai City
Shenzhen People's Hospital
Shenzhen
Tianjin Cancer Hospital
Tianjin
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City
Zhejiang Cancer Hospital
Zhejiang
France
Institut de Cancerologie de l Ouest
Angers
Institut Bergonie; Oncologie
Bordeaux
Centre Leon Berard; Departement Oncologie Medicale
Lyon
Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire
Marseille
Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs
Marseille Cedex 5
Institut de Recherche en Cancérologie de Montpellier
Montpellier Cedex 5
Institut Curie; Oncologie Medicale
Paris
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
Saint Herblain
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse
Institut Gustave Roussy; Pathologie Thoracique
Villejuif Cedex
Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden
Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
Göttingen
NCT Uniklinikum Heidelberg; Medizinische Onkologie
Heidelberg
Universitaetsklinikum Koeln; Innere Medizin I, Haematologie
Köln
Hong Kong Special Administrative Region
Princess Margaret Hospital
Hong Kong
The University of Hong Kong
Hong Kong
Queen Elizabeth Hospital
Kowloon
The Chinese University of Hong Kong
Shatin
Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
Milano
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano
Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia
Napoli
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica
Perugia
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
Pisa
Università Campus Bio-Medico di Roma; Oncologia Medica
Roma
Japan
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi
NHO Shikoku Cancer Center; Dept of Respiratory Medicine
Ehime
NHO Kyushu Cancer Center
Fukuoka
Hyogo Cancer Center, Dept of Respiratory Medicine
Hyogo
National Cancer Center Hospital; Dept of Respiratory Medicine
Kashiwa-shi
Miyagi Cancer Center; Respiratory Medicine
Miyagi
Niigata Cancer Center Hospital; Internal Medicine
Niigata
Kindai University Hospital; Medical Oncology
Osaka
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
Osaka
Shizuoka Cancer Center; Respiratory Internal Medicine
Shizuoka
Netherlands
NKI The Netherlands Cancer Institute
Amsterdam
Leids Universitair Medisch Centrum
Leiden
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology
Gliwice
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy
Poznań
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warszawa
Republic of Korea
Asan Medical Center.
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Singapore
National Cancer Centre
Singapore
National University Hospital; Haematology/Oncology
Singapore
Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona
Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit
Fuenlabrada
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid
Hospital Universitario La Paz; Servicio de Oncologia
Madrid
Hospital Universitario Ramon y Cajal; Servicio de Farmacia
Madrid
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla
Taiwan
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei City
United Kingdom
Addenbrookes Hospital
Cambridge
Sarah Cannon Research Institute
London
Christie Hospital Nhs Trust; Medical Oncology
Manchester
Time Frame
Start Date: November 19, 2015
Estimated Completion Date: April 1, 2025
Participants
Target number of participants: 700
Treatments
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)
Authors
Matthew Taylor, Jared Acoba, Dr. Christian Rolfo, Jonathan Treisman, Dr. Manuel Hidalgo Medina, Jonathan Polikoff, Paul Conkling, John Nemunaitis, Glen Weiss, Rakesh Surapaneni, Ignacio Garrido-Laguna, Pamela Crilley, Mary Chamberlin, David Chu, Dr. Thomas John, Helen Ross, Naveed Chowhan, Barbara Gitlitz, Fadi Braiteh, Jonathan Goldberg, Ding Wang, Dr. Rom Leidner, Elena Chiorean, Lyudmila Bazhenova, Jade Homsi, Tara Seery, Saiama Waqar, Arun Nagarajan, Shirish Gadgeel, Dr. Luis Paz-Ares Rodriguez, Eugene Ahn, Alexander Spira, Collin Blakely, Anna Farago, Conor Steuer, Anthony Conley, Richard Riedel, Sherronda Henderson, Robert Doebele, Edward Kim, Manish Patel, Dale Shepard, Stephen Liu, Theodore Pollock, Arthur Hooberman, Dylan Zylla, Surasak Phuphanich, Marwan Fakih, Darren Sigal, Arthur Frankel, John Krauss, Ashish Sangal, Alexander Drilon, Sant Chawla, Hari Deshpande, Kamalesh Sankhala, Petros Nikolinakos, Ioana Bonta, Christopher M. McCanless, Dr. Pilar Garrdio Lopez, Dr. Gee-Cheng Chang, Dr. Fabrice Barlesi, Dr. Benjamin Besse, Dr. Christian Grohe, Dr. Gunnar Folprecht, Dr. Philippe Cassier, Dr. Sophie Cousin, Dr. Diego Tosi, Dr. Christophe Le Tourneau, Dr. Juergen Wolf, Dr. Patrick Soulie, Dr. Jacques Medioni, Dr. Tobias Raphael Overbeck, Dr. Myoung-Ju Ahn, Dr. Ming-Lin Ho, Christine Chung, Dr. Joachim Von Pawel, Dr. Jose Manuel Trigo Perez, Dr. Robin Paterson, Dr. Maria Aslam, Dr. Yu Chung Li, Dr. Patrizia Racca, Dr. Weng Ng, Dr. Herbert Ho Fung Loong, Dr. Salvatore Siena, Dr. Simon Pacey, Dr. Alfredo Falcone, Dr. Emma Dean, Dr. Chris Karapetis, Hemant Patel, Dr. Vittorina Zagonel, Dr. Nuria Kotecki, Dr. Rodryg Ramlau, Dr. Craig Underhill, Dr. Giorgio Scagliotti, Dr. Hendrik-Tobias Arkenau, Dr. Dong-Wan Kim, Dr. Cinta Hierro, Dr. Jean-Pierre Delord, Dr. Krzysztof Skladowski, Dr. Egbert Smits, Dr. Yuichiro Oe, Dr. Foon Yiu Cheung, Dr. Chia Chi Lin, Dr. Laura Medina, Dr. Jesus Garcias-Donas, Pr. Florence Duffaud, Ian Anderson, Dr. Ki Hyeong Lee, Dr. Daniel Tan, Dr. Koichi Goto, Dr. Jesus Corral, Dr. Byoung Chul Cho, Dr. Chao-Hua Chiu, Dr. Filippo De Braud, Dr. Francesco Grossi, Dr. Giuseppe Tonini, Dr. Hans Gelderblom, Dr. Sang-We Kim, Dr. Thomas Chung Cheung Yau, Dr. Aleksandra Szczesna, Dr. Wu-Chou Su, Dr. Rita Chiari, Dr. Maciej Krzakowski, Dr. Francesco Leone, Dr. Jose Luis Gonzalez Larriba, Dr. Ashley Chi Kin Cheng, Dr. Cheng Ean Chee, Chae Young Kwang, Dr. Jose Miguel Sanchez Torres, Gregory Otterson, Dr. Fortunato Ciardello, Dr. Rafal Dziadziuszko, Dr. Javier de Castro Carpeno
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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