OncoMatch/Clinical Trials/NCT04774718
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
Is NCT04774718 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Alectinib for alk fusion-positive solid or cns tumors.
Treatment: Alectinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Biomarker criteria
Required: ALK fusion
Demographics
Prior therapy
Must have received: any prior anti-cancer therapy
prior treatment proven to be ineffective (i.e. relapsed or refractory), or for whom there is no satisfactory standard treatment available
Cannot have received: ALK inhibitor
prior use of ALK inhibitors
Cannot have received: stem cell infusion
stem cell infusions as defined by the protocol
Cannot have received: investigational therapy
Treatment with investigational therapy 28 days prior to initiation of study drug
Lab requirements
Blood counts
Adequate bone marrow function as defined by the protocol within at least 28 days prior to initiation of study drug
Kidney function
Kidney disease as defined by the protocol excluded
Liver function
Liver disease as defined by the protocol excluded
Adequate bone marrow function as defined by the protocol within at least 28 days prior to initiation of study drug; Liver or kidney disease as defined by the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lucile Packard Children's Hospital · Palo Alto, California
- Johns Hopkins All Children's Hospital · St. Petersburg, Florida
- University of Michigan, C.S. Mott Children's Hospital · Ann Arbor, Michigan
- Children's Minnesota · Minneapolis, Minnesota
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04774718 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ALK inhibitor, stem cell infusion, investigational therapy disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 17 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages