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news.Threshold Pharmaceuticals has reached an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma.
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The Phase 3 trial will be a 450 patient, randomized, open-label, multi-center trial comparing two treatment regimens for patients with metastatic and/or advanced unresectable soft tissue sarcoma who have not received prior doxorubicin.
This trial, which is expected to begin in the middle of 2011, is designed to demonstrate the clinical benefit of TH-302 in combination with doxorubicin compared to doxorubicin alone based on a primary efficacy endpoint of overall survival.
Threshold Pharmaceuticals VP of Biostatistics and Clinical Operations said the proposed trial is designed to confirm the encouraging results that they have previously reported in their ongoing Phase 1/2 trial of soft tissue sarcoma patients treated with TH-302 in combination with doxorubicin.