Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Astellas, Medivation Begin CRPC Enrollment | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Astellas, Medivation Begin CRPC Enrollment

Testing enzalutamide in patients with non-metastatic CRPC

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Medivation and Astellas Pharma have enrolled the first patient in a global Phase III clinical trial that will evaluate the safety and efficacy of enzalutamide in patients with non-metastatic (often referred to as M0) castration-resistant prostate cancer (CRPC). Currently no prescription medicine is specifically approved for the treatment of patients with non-metastatic CRPC in the U.S.

The randomized, double-blind, placebo-controlled, multi-national trial will enroll approximately 1,500 patients with non-metastatic CRPC at sites in the U.S., Canada, Europe, South America and the Asia-Pacific region. The trial will enroll a high-risk subgroup of patients with prostate cancer who are progressing despite androgen deprivation therapy, but who are asymptomatic with no prior or present evidence of metastatic disease. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, plus androgen deprivation therapy.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters