Eligible women had measurable, recurrent or persistent EOC/PPC and had received one or two prior regimens which must have contained a platinum and a taxane. Patients were treated with 100 mg orally daily of dasatinib continuously until progression of disease or adverse effects prevented further treatment. Primary endpoints were progression-free survival (PFS) ¡Ý 6 months and response rate. Serial plasma samples were assayed for multiple biomarkers. Circulating free DNA was quantified as were circulating tumor and endothelial cells.
Thirty-five (35) patients were enrolled in a two-stage sequential design. Of the 34 eligible and evaluable patients, 20.6 % (90 % confidence interval: 10.1 % , 35.2 % ) had a PFS ¡Ý 6 months; there were no objective responses. Grade 3-4 toxicities were gastrointestinal (mostly nausea and emesis; n = 4), pulmonary (dyspnea and/or pleural effusion; n = 4) and pain (n = 5), and infrequent instances of anemia, malaise, insomnia, rash, and central nervous system hemorrhage. Lack of clinical activity limited any correlation of biomarkers with outcome.
Dasatinib has minimal activity as a single-agent in patients with recurrent EOC/PPC.