You are here
Phase 3 Extension Trial Initiated of Toremifene Citrate for the Treatment of Side Effects Associated With Androgen Deprivation Therapy
Prostate cancer patients in the pivotal Phase III ADT trial who have completed the full two year treatment will be eligible to participate in the Phase IIIb extension trial for an additional year. The purpose of this study is to collect additional efficacy and safety data that could further support the current Phase III clinical study. This additional Phase IIIb clinical study is considered to be a separate clinical trial and will not affect the current timeline for the completion of the ongoing Phase III clinical trial in the second half of 2007 and the potential submission of the new drug application.
"This new clinical trial is a unique opportunity to continue to follow in a blinded fashion ADT patients completing our two year pivotal Phase III study. It will allow us not only to obtain additional data regarding fractures and safety, but also to evaluate other possible benefits of ACAPODENE in this population," said Mitchell S. Steiner, M.D., CEO of GTx.
Approximately 1,400 men have been enrolled into the pivotal Phase III clinical trial evaluating ACAPODENE for the treatment of side effects of androgen deprivation therapy for advanced prostate cancer. GTx completed enrollment of the trial in the fall of 2005. The primary endpoint of the trial, which is being conducted under a Special Protocol Assessment with the United States Food & Drug Administration, is a reduction in vertebral fractures. Secondary endpoints include improvements in bone mineral density and cholesterol levels, a reduction in hot flashes, and the treatment of gynecomastia. In December 2005, GTx conducted an interim analysis of bone mineral density in the first 200 men to complete one full year of treatment. The interim analysis demonstrated a highly statistically significant positive change in bone mineral density in patients treated with ACAPODENE versus patients on placebo.
Source: GTx, Inc.