Date: 2013-02-08
Type of information: Initiation of the trial
phase: 2
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: USA
Trial
details: The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated. (NCT01790126)
Latest
news: * On February 8, 2013, a Phase 2 trial sponsored by Aragon Pharmaceuticals was published on the NIH website ClinicalTrials.gov for apalutamide (ARN-509, JNJ-56021927) and is currently recruiting participants.
