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Brief Title: Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
Official Title: A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
Study ID: NCT02650401
Brief Summary: This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.
Detailed Description:
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Children'S Hospital of Orange County, Orange, California, United States
Rady Childrens Hospital, San Diego, California, United States
UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology, San Francisco, California, United States
Children's Hospital Colorado; Center For Cancer/Blood Disorder, Aurora, Colorado, United States
Children's National Medical Center; Department of Pediatrics, Washington, District of Columbia, United States
Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology, Atlanta, Georgia, United States
University of Chicago; Comer Children's Hospital/Department of Pediatrics, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Minnesota Childrens' Hospital, Minneapolis, Minnesota, United States
Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder, Saint Louis, Missouri, United States
Morgan Stanley Children's Hospital; Herbert Irving Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center; Pediatrics, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital; Dept. of Pulmonology, Columbus, Ohio, United States
Oregon Health & Science Uni, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude Children'S Research Hospital, Memphis, Tennessee, United States
Cook Childrens Medical Center, Fort Worth, Texas, United States
Texas Children's Cancer and Hematology Center, Houston, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
The Hospital for Sick Children, Toronto, Ontario, Canada
Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department, Beijing City, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Centre Leon Berard; Pediatrie, Lyon, , France
Hôpital de la Timone, Oncologie Pédiatrique, Marseille, , France
Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique, Toulouse, , France
Institut Gustave Roussy; Service de Pathologie Morphologique, Villejuif, , France
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Hong Kong Children's Hospital, Hong Kong, , Hong Kong
Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica, Milano, Lombardia, Italy
A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM, Torino, Piemonte, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia, Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Nino Jesus, Madrid, , Spain
National Taiwan University Hospital; Department of Paediatrics, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine, Taoyuan City, , Taiwan
Leeds General Infirmary, Leeds, , United Kingdom
Royal Victoria Infirmary; Pharmacy, Newcastle upon Tyne, , United Kingdom
Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR