Phase 2 Study of Avapritinib for Adults With CKIT or PDGFRA Mutation-Positive Advanced or Metastatic Malignant Solid Tumors

What this Trial Is About

Researchers are evaluating avapritinib in patients with malignant solid tumors that have genetic mutations in CKIT or PDGFRA and have spread locally or to other parts of the body. This phase II trial aims to determine how well avapritinib works to shrink tumors, control disease, and assess its safety and tolerability. The study also explores overall survival, response duration, progression-free survival, and the relationship between genetic mutations and treatment outcomes. Participants receive avapritinib orally once daily in 28-day cycles, continuing treatment as long as the disease does not progress and side effects remain manageable. After finishing treatment, patients have follow-up visits 30 days later and then every 8 weeks to monitor their condition. The study includes patients with various solid tumors such as melanoma, breast, lung, colorectal cancers, sarcoma, and primary central nervous system tumors, all confirmed to have the relevant mutations. Throughout the study, researchers assess tumor response using imaging criteria and monitor for adverse events using standard clinical scales. Laboratory tests, biopsies, and genomic analyses are performed to track treatment effects and mutations. Outcome measures include overall response rate, duration of response, disease control rate, and safety. Follow-up visits continue until study completion or disease progression, with participants expected to comply with scheduled visits and treatment protocols.

Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors