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

Recruiting now · Phase 1/Phase 2

Conditions studied: ALK Fusion-positive Solid or CNS Tumors

In brief

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.

Key facts

Study ID

NCT04774718

Run by

Hoffmann-La Roche

People needed

42

Starts

2021-09-14

Expected to finish

2032-02-28

Last updated by the study team

2026-08-06

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Lucile Packard Children's Hospital — Palo Alto, California, United States (enrolling)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• University of Michigan, C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Children's Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Hospital Universitari i Politecnic La Fe — Valencia, Spain (enrolling)
• Great Ormond Street Hospital — London, United Kingdom (enrolling)
• Royal Manchester Childrens Hospital — Manchester, United Kingdom (enrolling)
• Great North Children's Hospital — Newcastle upon Tyne, United Kingdom (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• St. Jude Children'S Research Hospital — Memphis, Tennessee, United States (enrolling)
• Sydney Children's Hospital — Randwick, New South Wales, Australia (enrolling)
• Royal Children's Hospital — Parkville, Victoria, Australia (enrolling)
• Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil (enrolling)
• Graacc-Grupo de Apoio ao adolescente e a crianca com cancer — São Paulo, São Paulo, Brazil (enrolling)
• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• CHU Sainte-Justine — Montreal, Quebec, Canada (enrolling)
• Beijing Children's Hospital, Capital Medical University — Beijing, China (enrolling)
• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (enrolling)
• Rigshospitalet — København Ø, Denmark (enrolling)
• Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique — Lyon, France (enrolling)
• Hôpital de la Timone, Oncologie Pédiatrique — Marseille, France (enrolling)
• Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris — Paris, France (enrolling)
• Istituto Nazionale Tumori di Milano — Milan, Lombardy, Italy (enrolling)
• Dipartimento di Scienze Pediatriche Adolescenza — Turin, Piedmont, Italy (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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