Date: 2015-08-21
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Aragon Pharmaceuticals (USA - CA), now Johnson&Johnson (J&J) (USA - NJ)
Product: apalutamide (ARN-509, JNJ-56021927)
Action
mechanism: antiandrogen/androgen receptor blocker. Apalutamide is a non-steroidal antiandrogen that is under development for the treatment of prostate cancer. The compound is acting as a selective competitive antagonist of the androgen receptor.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Israel, Republic of Korea, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey, Ukraine, UK, USA, Bulgaria
Trial
details: The ATLAS study is a randomized, double-blind, placebo-controlled phase 3 study of JNJ-56021927 in subjects with high-risk, localized or locally advanced prostate cancer receiving treatment with primary radiation therapy. The purpose of this study is to determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival. (NCT02531516)
Latest
news: * On August 8, 2015, a Phase 3 trial sponsored by Aragon Pharmaceuticals was published on the NIH website ClinicalTrials.gov for apalutamide (ARN-509, JNJ-56021927) and is currently recruiting participants.
