PRA's PPS facility in Budapest (PPS-Hungary) was contracted to run an open-label, non-randomized, Phase I study to characterize the mass balance and ADME pathways in advanced solid tumor patients with known deleterious BRCA1/2 mutations following a single oral dose of the study drug. The eligible patient pool for this study was substantially reduced due to an unexpected ethics committee (EC) requirement that the study only enroll BRCA+ patients. This limited population impacted the feasibility of the single-site study. PRA's collaborations across our extensive oncology networks produced the required number of patients to meet the EC's new criteria in less than 1 year. Our strategic focus ensured that all patients were enrolled in a reasonable timeframe and the client retained the single-site scenario with minimal impact on overall study timelines and budget.
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