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Brief Title: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
Official Title: A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available
Study ID: NCT04774718
Brief Summary: This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Lucile Packard Children's Hospital; Division of Child Neurology, Palo Alto, California, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
University of Michigan, C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
St. Jude Children'S Research Hospital, Memphis, Tennessee, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
The Hospital for Sick Children, Toronto, Ontario, Canada
CHU Sainte-Justine, Montreal, Quebec, Canada
Beijing Children's Hospital, Capital Medical University, Beijing City, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Rigshospitalet; Ny Medicin til Børn med Kræft, København Ø, , Denmark
Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique, Lyon, , France
Hôpital de la Timone, Oncologie Pédiatrique, Marseille, , France
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique, Paris, , France
Universitätsklinikum Heidelberg; KiTZ Hopp-Kindertumorzentrum, Heidelberg, , Germany
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS, Genova, Liguria, Italy
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica, Milano, Lombardia, Italy
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita, Torino, Piemonte, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Infantil Universitario Nino Jesus, Madrid, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Great Ormond Street Hospital, London, , United Kingdom
Royal Manchester Childrens Hospital, Manchester, , United Kingdom
Great North Children's Hospital, Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-LaRoche
Role: STUDY_DIRECTOR