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Spots Global Cancer Trial Database for A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

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Trial Identification

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

Interventions

Alectinib

Study Description

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:

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-LaRoche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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