A phase 2, open-label, single-arm monotherapy trial of Sulfasalazine in patients with PancrEatic AdenocaRcinoma: Statistical analysis plan for the SPEAR study

2025-12-05 oncology Title + abstract only

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BackgroundPancreatic ductal adenocarcinoma (PDAC) is associated with an extremely poor prognosis, with a 5-year survival rate of less than 9% (1). The SPEAR study is a Phase II, single-arm, open-label, signal-seeking trial evaluating the clinical activity of sulfasalazine, a repurposed anti-inflammatory agent, in patients with advanced or metastatic PDAC who have progressed on one prior line of systemic therapy. This document extends the published study protocol by pre-specifying the planned sta...