Ovarian Cancer AVB500-OC-004/ GOG-3059
Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
This is a randomize, double-blind Phase 3 study to compare the efficacy and safety of AVB-S6-500 in combination with paclitaxel (Pac) versus placebo in combination with Pac in patients with platinum resistant recurrent ovarian cancer.
Eligibility Criteria:
- Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy). Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
- Received at least 1 but not more than 4 prior therapy regimens since ovarian cancer diagnosis.
- Not being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- No tumors in the breast or bone.
This study is for patients age 18 and older.
Available at: Hartford Hospital, Hospital of Central Connecticut.