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news.Exelixis has initiated a Phase I/II trial of XL184 in patients with non-small cell lung cancer who have had progressive disease while on a regimen containing erlotinib.
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In the initial Phase I part of the study, safety and pharmacokinetics of combining XL184 with erlotinib will be evaluated. The primary endpoint of the Phase II part of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival and pharmacodynamics.
The Phase I/II study of XL184 is expected to enroll up to 86 non-small cell lung cancer (NSCLC) patients who have had disease progression while on erlotinib. Patients in the first cohort will receive a dose of XL184 that is below the maximum tolerated dose (MTD) identified in the ongoing Phase I 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 II portion of the study, patients will be randomized to receive XL184 at the MTD alone or in combination with erlotinib. XL184 is a small molecule that simultaneously inhibits the MET, RET and VEGFR receptor tyrosine kinases.
Michael Morrissey, president of research and development at Exelixis, said: “XL184 has shown encouraging anti-tumor activity in an initial Phase I trial and we are executing a Phase II clinical development program, and are planning on initiation of a pivotal trial for XL184 in medullary thyroid cancer in 2008.”