Two important new trials of enzalutamide and cabozantinib for patients with mCRPC


According to media releases from the relevant companies, two significant trials (of enzalutamide and of cabozantinib) are already or will soon be recruiting men with metastatic, castration-resistant prostate cancer (mCRPC).

In the first case, a media release from Medivation and from Astellas Pharma has announced the initiation of an expanded access trial of enzalutamide open to men with mCRPC who have cancer progression after prior treatment with docetaxel-based chemotherapy. Additional information about this trial (which will recruit patients at up to 75 centers in the USA) is already available on the ClinicalTrials.gov web site. Patients are already being recruited at 12 different centers around the country (of which seven are listed on the ClinicalTrials.gov web site).

In the second case, Exelixis has announced initiation of the so-called COMET-1 trial, which is a pivotal, randomized, Phase III  clinical trial of cabozantinib alone versus prednisone alone in men with mCRPC who have disease progression after prior treatment with docetaxel-based chemotherapy and either abiraterone acetate + prednisone or enzalutamide (also known as MDV3100). The primary endpoint for the COMET-1 study is overall survival, and Exelixis expects early data from COMET-1 to be available in the first half of 2014. Further information about the COMET-1 trial is also available on the ClinicalTrials.gov web site; as yet, however, this trial is not ready to recruit patients

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