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A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
NCT04774718 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Alectinib
Study Locations (20)
Other
- Beijing Children's Hospital, Capital Medical University — Beijing
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
- Rigshospitalet — København Ø
- Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique — Lyon
- Hôpital de la Timone, Oncologie Pédiatrique — Marseille
- Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris — Paris
- Universitätsklinikum Heidelberg — Heidelberg
São Paulo
- Hospital de Cancer de Barretos — Barretos
- Graacc-Grupo de Apoio ao adolescente e a crianca com cancer — São Paulo
California
- Lucile Packard Children's Hospital — Palo Alto
Florida
- Johns Hopkins All Children's Hospital — St. Petersburg
Michigan
- University of Michigan, C.S. Mott Children's Hospital — Ann Arbor
Minnesota
- Children's Minnesota — Minneapolis
New York
- Memorial Sloan Kettering Cancer Center — New York
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2032-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04774718
The ClinicalTrials.gov registry entry for NCT04774718 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with ALK Fusion-positive Solid or CNS Tumors appearing as the primary indexed condition, and to 1 intervention — of which Alectinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04774718 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, São Paulo, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04774718 about?
NCT04774718 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors". 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.
What is the current status of trial NCT04774718?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-09-14. Estimated completion is 2032-02-28.
What conditions does trial NCT04774718 study?
This clinical trial studies the following conditions: ALK Fusion-positive Solid or CNS Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04774718?
The interventions under investigation include: Alectinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04774718?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04774718 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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