Date: 2014-09-16
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Bayer Healthcare (Germany) Orion Corporation (Finland)
Product: ODM-201
Action
mechanism: ODM-201 is an investigational novel androgen receptor (AR) inhibitor with unique chemistry that is designed to block the growth of prostate cancer cells. ODM-201 binds to the AR with high affinity and inhibits receptor function by blocking its cellular function. In nonclinical models, ODM-201 has shown to only minimally penetrate the blood-brain barrier. A Phase II clinical trial conducted in patients with progressive metastatic castration-resistant prostate cancer assessed the efficacy and safety of three dose levels of ODM-201 (100mg, 200mg and 700mg given twice a day) in 124 patients. The study included patients who were treated previously with abiraterone and/or chemotherapy as well as patients who were chemotherapy-naïve. The results showed that ODM-201 provided disease suppression and had a favorable safety profile. The results were presented at the international ECCO oncology congress at the end of September 2013 and published in June 2014 in The Lancet Oncology.
Disease: castration-resistant prostate cancer (CRPC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The ARAMIS trial is a randomized, Phase III, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral ODM-201 in patients with non-metastatic CRPC who are at high risk for developing metastatic disease. About 1,500 patients are planned to be randomized in a 2:1 ratio to receive 600mg of ODM-201 twice a day or matching placebo. Randomization will be stratified by PSA doubling time (PSADT ? 6 months vs. > 6 months) and use of osteoclast-targeted therapy (yes vs. no). The primary endpoint of this study is metastasis-free survival (MFS), defined as time between randomization and evidence of metastasis or death from any cause. The secondary objectives of this study are overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, time to pain progression, and characterization of the safety and tolerability of ODM-201. (NCT02200614)
Latest
news: * On September 16, 2014, Bayer HealthCare and Orion Corporation have begun to enroll patients in a Phase III trial with ODM-201, an investigational novel oral androgen receptor (AR) inhibitor in clinical development for the treatment of patients with prostate cancer. The study, called ARAMIS, evaluates ODM-201 in men with castration-resistant prostate cancer (CRPC) who have rising Prostate-Specific Antigen (PSA) levels and no detectable metastases. The trial is designed to determine the effects of the treatment on metastasis-free survival (MFS). ?
Earlier this year, Bayer and Orion had entered into a global agreement under which they will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally and Orion has the option to co-promote ODM-201 in Europe. Orion will be responsible for the manufacturing of the product.
