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Exelixis Initiates Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer
Date:1/7/2008

administered daily. Patients in the first cohort will receive a dose of XL184 that is below the maximum tolerated dose (MTD) identified in the ongoing phase 1 trial of XL184, in combination with erlotinib. Subsequent cohorts will receive erlotinib in combination with escalating doses of XL184 until the MTD is reached. In the phase 2 portion of the study, patients will be randomized to receive XL184 at the MTD alone or in combination with erlotinib. Additionally, correlative studies will evaluate MET amplification and EGFR mutational status. MET and EGFR signaling activity will be assessed in tumor and surrogate tissue.

Data from an ongoing phase 1 trial of XL184 in patients with advanced malignancies were presented in October 2007 at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Abstract #A152). Investigators reported that anti-tumor activity had been observed in a variety of cancers at doses that are not associated with significant toxicity. There were 33 patients available for safety, pharmacokinetic and tumor response analyses as of the June 22, 2007 cutoff; further data were also provided for six additional patients after the cutoff. Of seven patients with medullary thyroid cancer (MTC), three had partial responses (two confirmed and one unconfirmed) as of the date of the AACR-NCI- EORTC Conference. In addition, as of such date, six of the seven patients had tumor shrinkage and one had non-measurable disease. All seven assessable patients with MTC experienced a rapid decrease in plasma levels of calcitonin, a marker frequently elevated in MTC, and six of the seven patients had a decrease in the tumor marker carcinoembryonic antigen. All seven MTC patients remain on study. In addition, one patient with a neuroendocrine tumor has an unconfirmed partial response. In total, 15 patients with various malignancies have had stable disease lasting from 3 - 20 months, including nine patients with stable disease for m
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SOURCE Exelixis, Inc.
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