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NCT04774718 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
A Phase 1 study of ALK Fusion-positive Solid or CNS Tumors, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT04774718 is a Phase 1 study of ALK Fusion-positive Solid or CNS Tumors that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 42 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT04774718, a Phase 1 study of ALK Fusion-positive Solid or CNS Tumors, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. 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 909 total studies on file at ClinicalTrials.gov.
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.
NCT04774718 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, São Paulo, California.
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.
What interventions are being tested in trial NCT04774718?
The interventions under investigation include: Alectinib (DRUG).
Who is sponsoring clinical trial NCT04774718?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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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