Exelixis is all set to commence the Phase 3 pivotal '306 trial of cabozantinib drug to treat metastatic castration-resistant prostate cancer (CRPC).
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Cabozantinib inhibits MET and VEGFR2 that suppress tumor growth, metastasis and angiogenesis in preclinical models.
The double-blind ‘306 trial is expected to enroll 246 CRPC patients, who will be randomised 1:1 to receive either cabozantinib or mitoxantrone/prednisone.
A Phase 2 trial conducted earlier demonstrated efficacy of cabozantinib on bone and soft tissue lesions, relief of bone metastasis-related pain in CRPC patients.
Exelixis president and CEO Michael Morrissey said the company also plans to start ‘307 trial in metastatic CRPC patients with an overall survival endpoint in the first half of 2012.
”Both trials provide a compelling opportunity to differentiate cabozantinib from other agents if improvements in both the quality and quantity of life are achieved," Morrissey added.
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