Alectinib for ALK Fusion-Positive Solid or CNS Tumors in Children
This study is testing alectinib, a medication, in children and teenagers (up to 17 years old) who have solid tumors or brain/spinal cord tumors (CNS tumors). These tumors must have a specific genetic change called an ALK gene fusion. You might be able to join if previous treatments haven't worked or if there isn't a standard treatment available. The study will look at how safe alectinib is, how the body processes it, and how well it works. Researchers will measure side effects, drug levels in the blood, and how many participants experience serious side effects in the first cycle. This study plans to enroll 42 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 42 participants.
- What's involved
- Participants will receive alectinib capsules twice daily for 28 days in each cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events and plasma concentration of alectinib for up to 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04774718
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
Active, Not Recruiting
PHASE1Up to 17InterventionalTreatmentHoffmann-La Roche
~42 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Alectinib
At a glance
Recruiting sites
0 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Participants with Dose-Limited Toxicities (DLTs)
Measured over Cycle 1 (cycle length = 28 days)
+4 more outcomes measured
Conditions
Where it's being run
31 sites across 21 statesFrance3
South Korea3
Spain3
United Kingdom3
São Paulo2
China2
California1
Florida1
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-LaRoche
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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)
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
For participants \< 16 years old, Lansky Performance Status \>/= 50%
For participants \>/= 16 years old, Karnofsky Performance Status \>/= 50%
Adequate bone marrow function as defined by the protocol within at least 28 days prior to initiation of study drug
Participant and/or caregiver willingness and ability to complete clinical outcome assessments throughout the study using either electronic, paper, or interviewer methods
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
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
Exclusion
Medical history of: prior use of ALK inhibitors; diagnosis of Anaplastic Large Cell Lymphoma (ALCL); any gastrointestinal disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection; history of organ transplant; stem cell infusions as defined by the protocol
Substance abuse within 12 months prior to screening
Familial or personal history of congenital bone disorders, bone metabolism alterations, or osteopenia
Treatment with investigational therapy 28 days prior to initiation of study drug
Liver or kidney disease as defined by the protocol
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade \>/=3 toxicities attributed to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with alectinib
Co-administration of anti-cancer therapies other than those administered in this study
Active hepatitis B or C virus (HBV, HBC), or known HIV-positivity or AIDS-related illness
Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the participant in this study
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; such conditions should be discussed with the participant before trial entry
Planned procedure or surgery during the study except as permitted treatment as defined by the protocol
Infection considered by the investigator to be clinically uncontrolled or of unacceptable risk to the participant upon induction of neutropenia, including participants who are, or should be, on antimicrobial agents for the treatment as active infection
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
What this trial measures
- Incidence of Participants with Dose-Limited Toxicities (DLTs)Cycle 1 (cycle length = 28 days)
- Percentage of Participants with Adverse EventsUp to 10 years
- Plasma Concentration of AlectinibUp to 10 years
- Plasma Concentration of Alectinib Metabolite (M4)Up to 10 years
- Confirmed Objective Response Rate (ORR): Defined as the Proportion of Participants with Complete Response (CR) or Partial Response (PR) on two Consecutive Occasions >/= 4 Weeks Apart, as Determined by Blinded Independent Central Review (BICR)Up to 10 years