Algeta completes successful sample size re-estimation of pivotal ALSYMPCA trial

04-May-2010 - Norway

Algeta ASA announced that the sample size re-estimation of its pivotal ALSYMPCA clinical trial, which was pre-planned for the first half of 2010, was completed on schedule. The sample size re-estimation confirmed that the current plan to recruit 750 patients into the ALSYMPCA study will meet the goals originally set for the study.

Algeta and its partner Bayer Schering Pharma AG have in parallel decided to increase recruitment for ALSYMPCA to 900 patients. This will increase the statistical power of the trial to 90% thereby further increasing the likelihood of proving the efficacy of Alpharadin. It will also allow the study to recruit US patients, and allow US clinical oncologists to gain experience with the use of Alpharadin. Recruitment in ALSYMPCA passed 600 patients during April.

Importantly, based on the rapid recruitment already seen in this pivotal study, Algeta and Bayer anticipate the enrolment of ALSYMPCA will still complete as planned in the second half of 2010 with results of the trial anticipated in 2012. This would allow for a filing in 2012 as planned.

Andrew Kay, Algeta’s President & CEO, said: “We are very pleased with the outcome of the sample size re-estimation as it confirms ALSYMPCA is a robust and well-designed trial. The trial recruitment rate is currently very good, and is expected to be boosted over the next few months as world-leading cancer centers in the USA come on-stream. This leads us to believe that the additional 150 patients can be enrolled in only a few months enabling us to complete recruitment in the second half of 2010.”

https://www.bionity.com/en/news/117178/algeta-completes-successful-sample-size-re-estimation-of-pivotal-alsympca-trial.html