Enhancing Inclusivity: Community-Focused Decentralization Of Avapritinib Phase 2 Basket Study For Improved Access And Community Engagement​

Summary:

Randomized clinical trials are the gold standard for clinical research and remain the most robust method for assessing the efficacy and safety of new therapeutic interventions. ​However, patients often must travel to academic centers, where investigators, diagnostics tools, and experimental therapeutics merge in a highly controlled environment. As a result, underserved and underrepresented minorities may not find it feasible to enroll in or sustain participation in a clinical trial.​ As a result of emerging technology, the constraints associated with a traditional trial design have been overcome, allowing more patients access to randomized clinical trials and innovative treatments closer to their homes. Despite the feasibility demonstrated in other medical fields, implementation of decentralized trials in oncology remains rare.​ The goal of this proposal is to bridge the gap between underserved communities surrounding Houston and access to an ongoing early-phase clinical trial (at the main campus) using avapritinib through decentralization as well as establish the framework for more inclusive and accessible clinical trial paradigms.​ They have multiple layers of infrastructure in place to remove barriers to community participation, enhance clinical trial diversity, increase rapport with the communities, and reimburse qualified patients for out-of-pocket expenses while participating. Telemedicine will be maximized for the trial, they have partnered with local healthcare facilities, imaging centers, and laboratories, and study drug will be shipped directly to the patient. ​Avapritinib is a potent, oral, selective small molecule inhibitor of KIT and PDGFRA-containing mutations. It has approval in gastrointestinal stromal tumors (GISTs) but KIT and PDGFRA mutations are present in 2.86% and 2.26% of all cancers, respectively.​ This phase II study will evaluate the overall response rate of avapritinib in patients with locally advanced or metastatic solid tumors with CKIT or PDGFRA mutations.

Trial Registration: ClinicalTrials.gov Identifier: NCT04773782