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ACTIVE NOT RECRUITINGPhase1/Phase2

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT04774718

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Alectinib (drug)
How long the study runs
Study runs about 125 months (dates as stated)
About the drug or intervention
Alectinib — drug: Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
Up to 17 Years
Who
All
Number of participants
42
Started
2021-09-14
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for alk fusion-positive solid or cns tumors
  • • Phase1/Phase2 - 42 participants
  • • 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

Who can take part?

  • • Ages Up to 17 Years
  • • Diagnosed with alk fusion-positive solid or cns tumors

Where?

  • • London - Great Ormond Street Hospital
  • • Manchester - Royal Manchester Childrens Hospital
  • • Newcastle upon Tyne - Great North Children's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

ALK Fusion-positive Solid or CNS Tumors

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Up to 17 Years
  • Who can join: All genders

Biomarkers mentioned

ALK

Treatment history

Treatments you must have had:

  • ✓ proven to be ineffective (i
  • ✓ such as radiotherapy (excluding alopecia)

What the study is looking for

  • ✓Inclusion Criteria
  • ✓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 the study treatment
  • ✓Participant and/or caregiver willingness and ability to complete clinical outcome assessments throughout the study...
See the full criteria
Inclusion Criteria * 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 Criteria * 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

Where Is This Study? (3 UK sites)

Great Ormond Street Hospital

London WC1N 3JH, United Kingdom

Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

Royal Manchester Childrens Hospital

Manchester M13 9WL, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Great North Children's Hospital

Newcastle upon Tyne NE1 4LP, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08