About the Phase 3 Sarcoma TrialThe 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 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. The trial includes an interim analysis based on progression-free survival expected to occur about half-way into enrollment and an interim analysis based on overall survival expected to occur at the end of enrollment. Patients will be randomized to receive TH-302 (300 mg/m 2 on days 1 and 8 of a 21 day cycle) in addition to the standard dosing schedule of doxorubicin (75 mg/m 2 on day 1 of the 21 day cycle) compared to doxorubicin alone. The Company plans to commence the trial in the middle of 2011.
Threshold Pharmaceuticals Announces Agreement With The FDA On A Special Protocol Assessment For Planned Phase 3 TH-302 Combination Trial In Advanced Soft Tissue Sarcoma
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