CTI: GOG Completes Patient Enrollment In GOG-0212 Phase 3 Study Of Opaxio

(RTTNews) - Cell Therapeutics, Inc. or CTI (CTIC) reported that the Gynecologic Oncology Group or GOG has completed patient enrollment in the GOG-0212 Phase 3 trial of investigational agent paclitaxel poliglumex or Opaxio as maintenance therapy in ovarian cancer.

"Although initial treatment is effective in putting this disease in remission, there is a high relapse rate for patients with ovarian cancer and there are limited treatment options when their cancer returns," said Larry Copeland, M.D., Department of Obstetrics and Gynecology, Ohio State University Comprehensive Cancer Center, Group Vice Chair of the GOG and chair of the GOG-0212 study.

The trial was designed to investigate whether Opaxio when used in a maintenance setting could keep these women in remission and therefore extend the lives of these patients. The study is being conducted and managed by the GOG, which is one of the National Cancer Institute's funded cooperative cancer research groups focused on the study of gynecologic malignancies.

The GOG-0212 trial is a randomized, multicenter, open label Phase 3 study of either monthly Opaxio or paclitaxel for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy. The study's primary endpoint is overall survival of patients treated with Opaxio compared to no maintenance therapy; while the secondary endpoints are progression-free survival, safety and quality of life.