Date: 2016-06-03
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Orion Corporation (Finland) Bayer (Germany)
Product: BAY-1841788/ODM-201 in combination with standard androgen deprivation therapy and docetaxel
Action
mechanism: androgen receptor antagonist. 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. The compound is currently in Phase III development ARAMIS study for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).
Disease: metastatic hormone sensitive prostate cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: ARASENS (A Randomized, double-blind, placebo-controlled Phase III study of ODM 201 versus placebo in addition to standard Androgen deprivation therapy and docetaxel in patients with metastatic castration SENSitive prostate cancer) is planned to be initiated towards the end of 2016. Approximately 1,300 patients will be randomized (1:1 ratio) to receive either BAY-1841788 or placebo in combination with an ADT of investigator’s choice (LHRH agonist/antagonists or orchiectomy), started ?12 weeks before randomization. Six cycles of docetaxel will be administered after randomization. The primary endpoint of the study is overall survival, and secondary endpoints include time to castration-resistant prostate cancer (time to CRPC), time to initiation of subsequent antineoplastic therapy, symptomatic skeletal event free survival (SSE-FS), time to first symptomatic skeletal event (time to SSE), time to initiation of opioid use, time to pain progression, time to worsening of physical symptoms of disease and safety.
Latest
news: * On June 3, 2016, Bayer and Orion Corporation announced the expansion of the global clinical development program for BAY-1841788 (ODM-201) in the area of prostate cancer. A new Phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy. The new trial ARASENS is expected to start the enrolment of patients towards the end of 2016. Bayer and Orion have recently expanded the 2014 agreement to include the joint development of BAY-1841788 (ODM-201) for mHSPC. Under that agreement, Bayer will commercialize the product globally; Orion has the option to co-promote BAY-1841788 in Europe, and is responsible for the manufacturing of the product.
