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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (3 UK sites)
Great Ormond Street Hospital
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Royal Manchester Childrens Hospital
Manchester M13 9WL, United Kingdom
Great North Children's Hospital
Newcastle upon Tyne NE1 4LP, United Kingdom
