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NCT04774718PHASE1, PHASE2Recruiting

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

Hoffmann-La Roche

Start Date

9/14/2021

Completion Date

2/28/2032

Summary

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.

Eligibility Criteria

Age Range: No minimum to 17 years

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

Interventions

DRUG

Alectinib

Interested in This Trial?

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Conditions

ALK Fusion-positive Solid or CNS Tumors

Locations

Lucile Packard Children's Hospital

Palo Alto, California 94304

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida 33701

United States

University of Michigan, C.S. Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

Children's Minnesota

Minneapolis, Minnesota 55404

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

St. Jude Children'S Research Hospital

Memphis, Tennessee 38105

United States

Sydney Children's Hospital

Randwick, New South Wales 2031

Australia

Royal Children's Hospital

Parkville, Victoria 3052

Australia

Hospital de Cancer de Barretos

Barretos, São Paulo 14784-400

Brazil

Graacc-Grupo de Apoio ao adolescente e a crianca com cancer

São Paulo, São Paulo 04038-030

Brazil

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

CHU Sainte-Justine

Montreal, Quebec H3T 1C5

Canada

Beijing Children's Hospital, Capital Medical University

Beijing, 100045

China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092

China

Rigshospitalet

København Ø, 2100

Denmark

Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique

Lyon, 69373

France

Hôpital de la Timone, Oncologie Pédiatrique

Marseille, 13385

France

Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

Paris, 75248

France

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

Genoa, Liguria 16147

Italy

Istituto Nazionale Tumori di Milano

Milan, Lombardy 20133

Italy

Dipartimento di Scienze Pediatriche Adolescenza

Turin, Piedmont 10126

Italy

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Infantil Universitario Nino Jesus

Madrid, 28009

Spain

Hospital Universitario Virgen del Rocio

Seville, 41 41013

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Great Ormond Street Hospital

London, WC1N 3JH

United Kingdom

Royal Manchester Childrens Hospital

Manchester, M13 9WL

United Kingdom

Great North Children's Hospital

Newcastle upon Tyne, NE1 4LP

United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT

United Kingdom