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Exelixis initiates phase II testing for XL880

Exelixis has moved its orally bioavailable small molecule inhibitor XL880 into phase II testing in patients with papillary renal cell carcinoma.

XL880 is a small molecule inhibitor of the receptor tyrosine kinases (RTKs) involved in tumor cell growth, migration and angiogenesis, including MET and VEGFR.

A multi-center open-label phase II study of the compound will be conducted in up to 15 clinical sites and is designed to enroll up to 34 patients with hereditary or sporadic papillary renal cell carcinoma. Primary objectives of the study are to determine best-confirmed response rate and to evaluate safety and tolerability of XL880 administered orally for five consecutive days every two weeks.

Secondary objectives are to assess progression-free survival, overall survival, duration of response and to continue characterizing the pharmacokinetic and pharmacodynamics profiles of XL880.

Subsequent phase II trials will be carried out in head and neck and gastric cancer.

“XL880 was the first MET inhibitor to enter clinical development and is now the first to advance to phase II clinical trials and we are very optimistic about the potential for XL880 to demonstrate benefit in this patient group,” commented George Scangos, president and CEO of Exelixis.