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Date: 2010-08-11
Phase: I-IIa
Anouncement: Launch
Biotech: Algeta (Norway)
Product: Alpharadin® (radium-223 chloride - first-in-class alpha-pharmaceutical)
Disease: Prostate cancer
Country: USA (Memorial Sloan-Kettering Cancer Center in New York and up to nine other centers in the USA)
Other: Algeta has treated the first patient in a phase I/IIa trial of Alpharadin in combination with docetaxel. The trial aims to recruit up to 60 men with bone metastases resulting from castration-resistant (hormone refractory) prostate cancer.
In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Alpharadin (See agreements)
Alpharadin is currently being evaluated in a global Phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant (hormone refractory) prostate cancer (CRPC), with overall survival as the primary endpoint. ALSYMPCA is recruiting from the approximately 50% of patients who are ineligible for treatment with docetaxel (based on clinical status and safety concerns) and those patients for whom chemotherapy is ineffective.
This trial (BC1-10) is a new combination study that will determine if the use of Alpharadin can be safely combined with docetaxel in patients who have bone metastases and can tolerate chemotherapy. This open-label, randomized phase I/IIa study aims to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from CRPC, to investigate safety and to explore efficacy of the recommended combination dose.
In the first part of the study, Alpharadin will be administered intravenously in a dose-escalating regimen in combination with standard docetaxel treatment (every three weeks). The maximum dose of Alpharadin will be 50 kBq/kg body weight every six weeks for five cycles.
In the second part of the study, patients will be randomized to receive standard docetaxel treatment every three weeks, or Alpharadin in combination with standard docetaxel treatment at the recommended dose.