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Threshold glufosfamide enters Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Threshold begins Phase III pancreatic cancer trial for glufosfamide following special protocol assessment agreement from FDA, the firm announces Sept. 13. The 306-patient study will randomize patients with metastatic pancreatic cancer refractory to first-line treatment to receive glufosfamide every three weeks on top of best supportive care or BSC alone. "As part of our registration and approval strategy, we are also planning to initiate, before the end of 2004, a Phase II clinical trial of glufosfamide in combination with Gemzar for the first-line treatment of inoperable locally advanced or metastatic pancreatic cancer," the firm says...
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