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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria.

  • - Histologically confirmed diagnosis of CNS or solid tumors harboring ALK gene fusions as determined locally by an appropriately validated assay performed in a CLIA-certified or equivalently-accredited diagnostic laboratory, or centrally by a Foundation Medicine Clinical Trial Assay (CTA) or the alternative, approved central laboratory for that region.
  • - 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 regiment administered and obtained prior to study enrollment, 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; 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04774718
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-LaRoche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Canada, Denmark, France, Italy, Korea, Republic of, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

ALK Fusion-positive Solid or CNS Tumors
Arms & Interventions

Arms

Experimental: ALK-Fusion Positive

Part 1 is a dose-confirmation phase to confirm the recommended phase 2 dose (RP2D). In Parts 2 and 3, participants will receive alectinib at the RP2D on Days 1-28 of each 28-day cycle

Interventions

Drug: - Alectinib

Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Palo Alto, California

Status

Not yet recruiting

Address

Lucile Packard Children's Hospital; Division of Child Neurology

Palo Alto, California, 94304

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida

Status

Not yet recruiting

Address

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Ann Arbor, Michigan

Status

Not yet recruiting

Address

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

Ann Arbor, Michigan, 48109

Children's Minnesota, Minneapolis, Minnesota

Status

Not yet recruiting

Address

Children's Minnesota

Minneapolis, Minnesota, 55404

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Cincinnati, Ohio

Status

Not yet recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

St. Jude Children'S Research Hospital, Memphis, Tennessee

Status

Not yet recruiting

Address

St. Jude Children'S Research Hospital

Memphis, Tennessee, 38105

Texas Children's Hospital, Houston, Texas

Status

Not yet recruiting

Address

Texas Children's Hospital

Houston, Texas, 77030

International Sites

Sydney Children's Hospital, Randwick, New South Wales, Australia

Status

Recruiting

Address

Sydney Children's Hospital

Randwick, New South Wales, 2031

Royal Children's Hospital, Parkville, Victoria, Australia

Status

Not yet recruiting

Address

Royal Children's Hospital

Parkville, Victoria, 3052

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

CHU Sainte-Justine, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5

Ny Medicin til Børn med Kræft, København Ø, Denmark

Status

Recruiting

Address

Ny Medicin til Børn med Kræft

København Ø, , 2100

Lyon, France

Status

Not yet recruiting

Address

Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique

Lyon, , 69373

Marseille, France

Status

Recruiting

Address

Hôpital de la Timone, Oncologie Pédiatrique

Marseille, , 13385

Paris, France

Status

Recruiting

Address

Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

Paris, , 75248

Genova, Liguria, Italy

Status

Not yet recruiting

Address

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

Genova, Liguria, 16147

Milano, Lombardia, Italy

Status

Not yet recruiting

Address

Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

Milano, Lombardia, 20133

Torino, Piemonte, Italy

Status

Not yet recruiting

Address

Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

Torino, Piemonte, 10126

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Madrid, Spain

Status

Not yet recruiting

Address

Hospital Infantil Universitario Nino Jesus

Madrid, , 28009

Hospital Universitari i Politecnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

Valencia, , 46026

Great Ormond Street Hospital, London, United Kingdom

Status

Not yet recruiting

Address

Great Ormond Street Hospital

London, , WC1N 3JH

Royal Manchester Childrens Hospital, Manchester, United Kingdom

Status

Not yet recruiting

Address

Royal Manchester Childrens Hospital

Manchester, , M13 9WL

Great North Children's Hospital, Newcastle upon Tyne, United Kingdom

Status

Not yet recruiting

Address

Great North Children's Hospital

Newcastle upon Tyne, , NE1 4LP

Royal Marsden Hospital (Sutton), Sutton, United Kingdom

Status

Not yet recruiting

Address

Royal Marsden Hospital (Sutton)

Sutton, , SM2 5PT