Women's Health Weekly
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Clinical Trials
Phase 3 trial of paclitaxel compound for treating metastatic breast cancer initiated
November 3rd, 2005
Sonus Pharmaceuticals, Inc. (SNUS) announced the initiation of the pivotal phase 3 trial of Tocosol Paclitaxel intended to serve as the basis for approval of the product by the U.S. Food and Drug Administration (FDA). The two-arm, randomized study is being conducted under a Special Protocol Assessment (SPA) that Sonus completed with the FDA in June 2005. The trial will enroll approximately 800 women with metastatic breast cancer, who will receive either Tocosol Paclitaxel or Taxol on a weekly dosing schedule. The phase 3 study's primary endpoint is objective response rate (ORR), and the new drug application (NDA) will be submitted based on analyses...
Source: Women's Health Weekly (2005-11-03)
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