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

Description

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.

Conditions

ALK Fusion-positive Solid or CNS Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
ALK Fusion-positive Solid or CNS Tumors
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Lucile Packard Children's Hospital; Division of Child Neurology, Palo Alto, California, United States, 94304

Saint Petersburg

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701

Ann Arbor

University of Michigan, C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States, 48109

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 11101

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Memphis

St. Jude Children'S Research Hospital, Memphis, Tennessee, United States, 38105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    to 17 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Hoffmann-La Roche,

    Clinical Trials, STUDY_DIRECTOR, Hoffmann-LaRoche

    Study Record Dates

    2030-07-03