A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors (NCT04774718)

🧪 Interventions in This Study

• Alectinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-existing NGS test results
2. Disease status: prior treatment proven to be ineffective (i.e. relapsed or refractory), or for whom there is no satisfactory standard treatment available. Disease should be measurable and evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or Response Assessment in Neuro-oncology criteria (RANO) +/- bone marrow criteria for primary CNS tumors or International Neuroblastoma Response Criteria (INRC)
3. Available tumor tissue for submission to the Sponsor from active disease, obtained subsequent to last anti-cancer therapy regimen administered and obtained prior to study enrollment (preferred option), or archival tumor tissue from original diagnosis, or willingness to undergo a core or excisional biopsy sample collection prior to enrollment
4. For participants \< 16 years old, Lansky Performance Status \>/= 50%
5. For participants \>/= 16 years old, Karnofsky Performance Status \>/= 50%
6. Adequate bone marrow function as defined by the protocol within at least 28 days prior to initiation of study drug
7. Participant and/or caregiver willingness and ability to complete clinical outcome assessments throughout the study using either electronic, paper, or interviewer methods
8. For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined by the protocol
9. For males who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm, as defined by the protocol

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (31 Sites)

Showing the first 25 of 31 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
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
• St. Jude Children'S Research Hospital — Memphis, Tennessee
• Sydney Children's Hospital — Randwick, New South Wales
• Royal Children's Hospital — Parkville, Victoria
• Hospital de Cancer de Barretos — Barretos, São Paulo
• Graacc-Grupo de Apoio ao adolescente e a crianca com cancer — São Paulo, São Paulo
• The Hospital for Sick Children — Toronto, Ontario
• CHU Sainte-Justine — Montreal, Quebec
• 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,
• Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS — Genoa, Liguria
• Istituto Nazionale Tumori di Milano — Milan, Lombardy
• Dipartimento di Scienze Pediatriche Adolescenza — Turin, Piedmont
• Seoul National University Hospital — Seoul,
• Asan Medical Center — Seoul,
• Samsung Medical Center — Seoul,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All ALK Fusion-positive Solid or CNS Tumors clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.