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Active, not recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04774718

Public ClinicalTrials.gov record NCT04774718. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 5, 2026, 4:22 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04774718
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
42 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2021 (Actual)
Primary completion
Feb 28, 2032 (Estimated)
Completion
Feb 28, 2032 (Estimated)
Last update posted
Aug 14, 2026

2021 – 2032

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Lucile Packard Children's Hospital Palo Alto California 94304 —
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 —
University of Michigan, C.S. Mott Children's Hospital Ann Arbor Michigan 48109 —
Children's Minnesota Minneapolis Minnesota 55404 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
St. Jude Children'S Research Hospital Memphis Tennessee 38105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04774718, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 14, 2026 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04774718 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →