New hope for kids with rare cancers: alectinib trial launches
NCT ID NCT04774718
First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 6 times
Summary
This study tests the drug alectinib in children and teens with ALK fusion-positive solid or central nervous system (CNS) tumors that have not responded to other treatments or have no standard therapy. The goal is to see if alectinib is safe and can shrink or control these tumors. About 42 participants will take alectinib capsules twice daily in 28-day cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alectinib
- What this could lead to
- If it works, this could provide a new treatment option for children with these rare, hard-to-treat tumors.
- What could go wrong
- This is an early-phase trial with only 42 participants, so results may not apply to all patients. Side effects are possible, and the drug may not shrink tumors in everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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Beijing Children's Hospital, Capital Medical University
Beijing, 100045, China
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CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
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Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique
Lyon, 69373, France
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Children's Minnesota
Minneapolis, Minnesota, 55404, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Dipartimento di Scienze Pediatriche Adolescenza
Turin, Piedmont, 10126, Italy
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Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, 04038-030, Brazil
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Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP, United Kingdom
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Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
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Hospital Infantil Universitario Nino Jesus
Madrid, 28009, Spain
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Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
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Hospital Universitario Virgen del Rocio
Seville, 41 41013, Spain
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Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
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Hôpital de la Timone, Oncologie Pédiatrique
Marseille, 13385, France
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Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
Paris, 75248, France
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Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
Genoa, Liguria, 16147, Italy
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Istituto Nazionale Tumori di Milano
Milan, Lombardy, 20133, Italy
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Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
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Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Rigshospitalet
København Ø, 2100, Denmark
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Royal Children's Hospital
Parkville, Victoria, 3052, Australia
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Royal Manchester Childrens Hospital
Manchester, M13 9WL, United Kingdom
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Samsung Medical Center
Seoul, 06351, South Korea
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Seoul National University Hospital
Seoul, 03080, South Korea
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St. Jude Children'S Research Hospital
Memphis, Tennessee, 38105, United States
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Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
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The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
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University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
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Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
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