Actively Recruiting
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
Led by Hoffmann-La Roche · Updated on 2026-05-05
42
Participants Needed
33
Research Sites
545 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CNS or solid tumors with documented ALK gene fusions
- Disease status: relapsed, refractory, or no satisfactory standard treatment available
- Measurable and evaluable disease by RECIST v1.1, RANO, or INRC criteria
- Available tumor tissue for submission or willingness to undergo biopsy prior to enrollment
- Lansky Performance Status 50% for participants under 16 years
- Karnofsky Performance Status 50% for participants 16 years or older
- Adequate bone marrow function within 28 days before starting study drug
- Willingness and ability to complete clinical outcome assessments
- For females of childbearing potential: agreement to remain abstinent or use contraception and not donate eggs
- For males not surgically sterile: agreement to remain abstinent or use contraception and not donate sperm
You will not qualify if you...
- Prior use of ALK inhibitors
- Diagnosis of Anaplastic Large Cell Lymphoma (ALCL)
- Gastrointestinal disorders affecting oral medication absorption
- History of organ transplant or stem cell infusions
- Substance abuse within 12 months prior to screening
- Familial or personal history of congenital bone disorders or osteopenia
- Treatment with investigational therapy within 28 days before study drug
- Liver or kidney disease as defined by protocol
- Grade 3 toxicities from prior therapy interfering with alectinib
- Use of other anti-cancer therapies during the study
- Active hepatitis B or C, HIV-positive status, or AIDS-related illness
- Any condition interfering with study conduct or drug absorption
- Psychological, familial, sociological, or geographical conditions hampering study compliance
- Planned surgery or procedure during the study unless permitted
- Uncontrolled or high-risk infections
- Pregnancy, breastfeeding, or intention to become pregnant during or within 3 months after study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
2
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
3
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Children's Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
St. Jude Children'S Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
8
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
9
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
10
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
11
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, Brazil, 04038-030
Actively Recruiting
12
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
13
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
14
Beijing Children's Hospital, Capital Medical University
Beijing, China, 100045
Actively Recruiting
15
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Actively Recruiting
16
Rigshospitalet
København Ø, Denmark, 2100
Actively Recruiting
17
Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique
Lyon, France, 69373
Actively Recruiting
18
Hôpital de la Timone, Oncologie Pédiatrique
Marseille, France, 13385
Actively Recruiting
19
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
Paris, France, 75248
Actively Recruiting
20
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Withdrawn
21
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
Genoa, Liguria, Italy, 16147
Active, Not Recruiting
22
Istituto Nazionale Tumori di Milano
Milan, Lombardy, Italy, 20133
Actively Recruiting
23
Dipartimento di Scienze Pediatriche Adolescenza
Turin, Piedmont, Italy, 10126
Actively Recruiting
24
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
25
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
26
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
27
Hospital Infantil Universitario Nino Jesus
Madrid, Spain, 28009
Actively Recruiting
28
Hospital Universitario Virgen del Rocio
Seville, Spain, 41 41013
Actively Recruiting
29
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
30
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
31
Royal Manchester Childrens Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
32
Great North Children's Hospital
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
33
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
R
Reference Study ID Number: GO42286 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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