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
Study Director: Clinical Trials, F. Hoffmann-La Roche
Description: Researchers are conducting a phase 1/2 trial to test alectinib in pediatric patients with ALK fusion-positive solid tumors or central nervous system (CNS) tumors.
In the first part of the trial, researchers will determine the recommended phase 2 dose of alectinib. In parts 2 and 3, researchers will test the recommended dose for efficacy and safety.
Patients will receive alectinib twice daily on days 1 through 28 of each cycle. Primary outcome measures include dose-limiting toxicities, the incidence of adverse events, the plasma concentration of alectinib, and the confirmed objective response rate.
To be eligible for this study, patients must be 17 years of age or younger. They must have a histologically confirmed diagnosis of ALK fusion-positive CNS or solid tumors for which prior treatment was ineffective or for which there is no satisfactory standard treatment available. For a full list of eligibility criteria, please see the reference.
This study is sponsored by F. Hoffmann-La Roche.
ClinicalTrials.gov. A study evaluating the safety, pharmacokinetics, and efficacy of alectinib in pediatric participants with ALK fusion-positive solid or CNS tumors. NCT04774718. Accessed July 19, 2022.