Threshold Pharmaceuticals, Inc. Initiates Phase 3 TH-302 Combination Trial In Advanced Soft Tissue Sarcoma

Threshold Pharmaceuticals, Inc. announced that Threshold, in collaboration with Sarcoma Alliance for Research through Collaboration (SARC), have initiated a Phase 3 randomized clinical trial of TH-302 in patients with soft tissue sarcoma. This international pivotal trial will enroll patients with metastatic or locally advanced unresectable soft tissue sarcoma who have not previously received chemotherapy outside the adjuvant or neoadjuvant setting. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with doxorubicin, compared to doxorubicin alone. Following an end of Phase 2 meeting with the FDA, the Phase 3 protocol has been agreed upon under a Special Protocol Assessment (SPA). As part of that assessment, the FDA agreed that the design and planned analysis of the study adequately addresses the objectives necessary to support a regulatory submission for approval with enrollment expected to be completed by the end of 2013.