...The Company is currently conducting a Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with advanced, recurrent or metastatic endometrial cancer who have progressed and have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment). Conducted under a Special Protocol Assessment, the trial compares zoptarelin doxorubicin with doxorubicin. The primary efficacy endpoint is improvement in median Overall Survival. At present time, site initiation has been completed with over 120 sites in operation in North America, Europe and Israel; as well, patient recruitment (500) was completed in June 2015.
Following its first futility interim analysis, an independent data and safety monitoring board (DSMB) has recommended that the trial continue as planned. A second interim analysis is expected by year-end 2015.
To find out more about this trial, please visit this link.
Furthermore, zoptarelin doxorubicin is being investigated in Phase 2 trials in prostate and breast cancer....
Warum interim analysis erst by the end of 2015???? Dachte diese / nächste Woche???
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