Randomized phase 3, multicenter, open-label study comparing evofosfamide (Evo) in combination with doxorubicin (D) vs. D alone in patients (pts) with advanced soft tissue sarcoma (STS): Study TH-CR-406/SARC021

Abstract

Methods: This was a multi-national, open-label, randomized (1:1) Phase 3 study of Evo (300 mg/m2) IV on Days 1 and 8 (21-day cycle) with D on Day 1 vs. D alone (75 mg/m2, bolus or continuous). Pts on Evo plus D could receive Evo alone after Cycle 6. Key eligibility: locally advanced unresectable or metastatic STS, intermediate or high grade, no prior chemotherapy for advanced disease, ECOG 0/1, measurable disease (RECIST 1.1). The primary endpoint was overall survival (OS). The study had 85% power and one-sided alpha of 2.5% to detect 33% improvement in OS. Secondary endpoints were PFS, response rate (RR) and safety.