Exelixis begins phase 2 program for XL880 in patients with papillary renal cell carcinoma

By E. Janene Geiss

Philadelphia, June 28 - Exelixis, Inc. announced Wednesday the start of a phase 2 program for XL880, an orally bioavailable small molecule inhibitor of the receptor tyrosine kinases involved in tumor cell growth, migration and angiogenesis including hepatocyte growth factor receptor (MET) and vascular endothelial growth factor (VEGFR).

The multi-center open-label phase 2 study 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, according to a company news release.

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, officials said.

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

Subsequent phase 2 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 2 clinical trials, officials said.

As reported by investigators in June at the American Society of Clinical Oncology annual meeting, XL880 has exhibited favorable safety and tolerability profiles in a phase 1 trial in patients with advanced solid tumors.

Of 19 patients evaluable for tumor responses in the phase 1 trial, officials said, two patients with papillary renal cell carcinoma had partial responses and seven other patients with a variety of tumors had stable disease for three to 13 months.

Additionally, analysis of biopsy samples taken from a patient with melanoma who showed tumor reduction indicated that XL880 inhibited the activation of MET, RON, ERK and AKT and decreased proliferation and increased apoptosis in the tumor sample, officials said.

These changes were not observed in samples of normal tissue taken from the same patient.

XL880 is an orally available small molecule compound designed to target multiple RTKs implicated in the development, progression and spread of cancer.

Exelixis is a South San Francisco, Calif., biotechnology company.

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