Phase Ii Clinical Trial Evaluating Crlx101 In Recurrent Ovarian, Tubal, And Peritoneal Cancer.

5581 Background: Ovarian cancer (Ov.Ca.) is the leading cause of death among gyn malignancies in the United States with over 20,000 new cases diagnosed in 2013. Limited treatment options exist for women whose tumors have progressed after 1st-line platinum-based therapy. Current approved therapy for relapsed Ov.Ca. includes the topo-1 inhibitor topotecan, which provides limited survival benefit and remains compromised by toxicity. CRLX101 is a novel cyclodextrin-containing polymer conjugate of camptothecin (CPT) that self-assembles into nanoparticles and delivers sustained CPT into cancer cells while reducing systemic exposure. In vitro and in vivodata suggest superior activity of CRLX101 compared to approved agents in Ov.Ca. models. The monotherapy MTD of 15 mg/m2 IV q. 2 wks. has now been administered to over 200 solid tumor pts (pts.) across 7 clinical trials. Methods: This phase 2 clinical trial evaluated CRLX101 in pts. with relapsed Ov.Ca. progressing after 1-3 prior regimens of chemotherapy, and inc...