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Home » Exelixis, FDA Agree on Special Protocol Assessment
Exelixis, FDA Agree on Special Protocol Assessment
June 17, 2008
Exelixis and the FDA have reached agreement on the registration trial of XL184, a small molecule anti-cancer compound, as part of the Special Protocol Assessment process.
This summer, the company plans to initiate a randomized, placebo-controlled, double-blinded Phase III study of the drug as single-agent therapy in 315 patients with unresectable, locally advanced or metastatic medullary thyroid cancer.
The primary endpoint will be duration of progression-free survival, Exelixis said.
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