Date: 2015-07-01
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, Australia, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, Israel, Japan, Republic of Korea, Mexico, Poland, Romania, Russian Federation, Spain, Sweden, Turkey, Ukraine, UK, USA
Trial
details: The TITAN study is a phase 3 randomized, placebo-controlled, double-blind study of apalutamide plus androgen deprivation therapy (ADT) versus ADT in subjects with metastatic hormone-sensitive prostate cancer (mHSPC). The purpose of the TITAN study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC. (NCT02489318)
Latest
news: * On July 1, 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.
