A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA Signaling
Primary Objective
Patients are being asked to participate in a research study because they have a type of solid tumor or a CNS tumor (a tumor originating in the brain or spine) with specific mutations for which standard therapy has not worked or where there is no alternative treatment.
Description
There are two parts planned for this study, the Phase 1 that will test different doses of avapritinib to identify the recommended dose of avapritinib for the Phase 2. The Phase 2 will continue to test this recommended dose of avapritinib to determine if it is a tolerable, safe, and effective treatment for subjects with solid tumors dependent on KIT or PDGFRA function. The avapritinib dose should be administered once every day, at approximately the same time each day, ideally in the morning. Generally, it is expected that subjects will participate for minimum duration of approximately 3 months but there is no defined maximum duration.
Details
Locations
Childrens Hospital Colorado
Principal Investigator
Kathleen Dorris
Study ID
Protocol Number: 21-4262
More information available at ClinicalTrials.gov: NCT04773782
Categories
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