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NCT04774718
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
Phase 1, PHASE2 trial testing Alectinib in ALK Fusion-positive Solid or CNS Tumors in 42 participants. Currently enrolling.
28 February 2032
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 14 September 2021 |
| Primary completion | 28 February 2032 |
| Estimated completion | 28 February 2032 |
| Sites | 33 locations across Denmark, France, Italy, United Kingdom, Germany, South Korea, Canada, Australia |
Drugs / interventions tested
- Alectinib — full drug profile →
Conditions studied
- ALK Fusion-positive Solid or CNS Tumors — all drugs for ALK Fusion-positive Solid or CNS Tumors →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Under 17, any sex, with ALK Fusion-positive Solid or CNS Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
ALK fusions in the pan-cancer setting: another tumor-agnostic target?
Shreenivas A, Janku F, Gouda MA, Chen HZ, et al · · 2023 · cited 60× · PMID 37773318 · DOI 10.1038/s41698-023-00449-x -
Case report: ATIC-ALK fusion in infant-type hemispheric glioma and response to lorlatinib.
Shahab SW, Schniederjan M, Vega JV, Little S, et al · · 2023 · cited 8× · PMID 36910660 · DOI 10.3389/fonc.2023.1123378 -
Targeting the RET tyrosine kinase in neuroblastoma: A review and application of a novel selective drug design strategy.
Steen EA, Basilaia M, Kim W, Getz T, et al · · 2023 · cited 7× · PMID 37595672 · DOI 10.1016/j.bcp.2023.115751 -
Genomics-Driven Precision Medicine in Pediatric Solid Tumors.
Suthapot P, Chiangjong W, Chaiyawat P, Choochuen P, et al · · 2023 · cited 7× · PMID 36900212 · DOI 10.3390/cancers15051418 -
Evolving Diagnostic and Treatment Strategies for Pediatric CNS Tumors: The Impact of Lipid Metabolism.
Fernández-García P, Malet-Engra G, Torres M, Hanson D, et al · · 2023 · cited 5× · PMID 37239036 · DOI 10.3390/biomedicines11051365 -
Tissue-agnostic biomarkers in solid tumors: current approvals and emerging candidates.
Kim J, Kim HS, Nam M, Chae YK. · · 2025 · cited 3× · PMID 40576713 · DOI 10.1007/s10555-025-10274-2 -
Relative bioavailability and food effect study of an oral suspension of alectinib in healthy volunteers using venipuncture and capillary microsampling.
Liu SN, Agarwal P, Heinig K, Datye A, et al · · 2023 · cited 1× · PMID 36978270 · DOI 10.1111/cts.13515 -
Sarcomas in Adolescents and Young Adults.
Greenmyer JR, Allen-Rhoades W. · · 2026 · PMID 42159886 · DOI 10.1007/s11912-026-01781-8
Verify or expand the search:
- PubMed search for NCT04774718
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04774718 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04774718.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing