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:

1. Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
2. 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.
3. Received at least 1 but not more than 4 prior therapy regimens since ovarian cancer diagnosis.
4. Not being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
5. No tumors in the breast or bone.

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut.