RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

Quick Facts

Study Start:2021-09-14
Study Completion:2030-07-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04774718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Reference Study ID Number: GO42286 https://forpatients.roche.com/
CONTACT
888-662-6728
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-LaRoche

Study Locations (Sites)

Lucile Packard Children's Hospital; Division of Child Neurology
Palo Alto, California, 94304
United States
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
United States
University of Michigan, C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 11101
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
St. Jude Children'S Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-LaRoche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-14
Study Completion Date2030-07-03

Study Record Updates

Study Start Date2021-09-14
Study Completion Date2030-07-03

Terms related to this study

Additional Relevant MeSH Terms

  • ALK Fusion-positive Solid or CNS Tumors