RecruitingPhase 1Phase 2NCT04774718

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

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


Sponsor

Hoffmann-La Roche

Enrollment

42 participants

Start Date

Sep 14, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Alectinib for people with alk fusion-positive solid or cns tumors. The study is currently recruiting participants at 33 locations. People eligible for this study include up to age 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlectinib

Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle


Locations(33)

Lucile Packard Children's Hospital

Palo Alto, California, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

University of Michigan, C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Minnesota

Minneapolis, Minnesota, 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

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Graacc-Grupo de Apoio ao adolescente e a crianca com cancer

São Paulo, São Paulo, Brazil

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Beijing Children's Hospital, Capital Medical University

Beijing, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Rigshospitalet

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

Paris, France

Universitätsklinikum Heidelberg

Heidelberg, Germany

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

Genoa, Liguria, Italy

Istituto Nazionale Tumori di Milano

Milan, Lombardy, Italy

Dipartimento di Scienze Pediatriche Adolescenza

Turin, Piedmont, Italy

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, 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

View Full Details on ClinicalTrials.gov

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NCT04774718