Date: 2014-04-02
Type of
information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Bayer HealthCare (Germany) Janssen Research and Development - J&J (USA - NJ)
Product: combination of Xofigo® (radium-223 dichloride), Zytiga® (abiraterone) and prednisone/prednisolone
Action
mechanism:
- radiopharmaceutical/androgen synthesis inhibitor. Radium 223 chloride (Xofigo®) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in radium 223 is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of radium-223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue. It has been approved under the brand name Xofigo® by the European Commission for the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases. In the U.S., it is approved for the treatment of CRPC patients with symptomatic bone metastases and no known visceral metastatic disease.
Abiraterone acetate (Zytiga®) is a prescription medicine that is used along with prednisone. Abiraterone acetate is the prodrug of abiraterone that works by inhibiting the CYP17 enzyme complex in the androgen biosynthesis pathway which is important in the production of testosterone and other androgens. This pathway is also present in the testes, adrenal gland and the prostate tumor tissue. In the EU, it is marketed under the brand name Zytiga® and indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated or whose disease has progressed on or after a docetaxel based chemotherapy regimen.
Disease: treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (CRPC)
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Brazil, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Poland, Russian Federation, Singapore, Spain, USA
Trial
details:
- The randomized double-blind, placebo-controlled Phase III trial will investigate whether providing radium-223 dichloride (radium-223) in combination with abiraterone acetate and prednisone/prednisolone will increase symptomatic skeletal event free survival (SSE-FS). The trial will enroll approximately 800 patients who will be randomized in a 1:1 ratio to receive study treatment (either radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone/prednisolone and best supportive care for the first six cycles followed by abiraterone acetate plus prednisone/prednisolone thereafter) until an on-study symptomatic skeletal event (SSE) occurs (or other withdrawal criteria are met). (NCT02043678)
Latest
news:
- • On April 2, 2014, Bayer HealthCare has announced that the company has begun to enroll patients in a new Phase III trial with radium-223 dichloride (radium-223, Xofigo®). The study evaluates radium-223 in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (CRPC). The trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival (SSE-FS). The international study will be sponsored by Bayer and conducted in collaboration with Janssen Research and Development in various regions including sites in Europe, the U.S., Australia, Brazil and Japan.
Is
general: Yes
