A phase 1b dose escalation study of ipafricept (OMP54F28) in combination with paclitaxel and carboplatin in patients with recurrent platinum-sensitive ovarian cancer
Gynecologic Oncology Jun 11, 2019
Moore KN, et al. - Researchers conducted this phase Ib trial investigating the maximum tolerated dose and recommended phase 2 dose for ipafricept [IPA; it blocks Wnt signaling, an important oncologic driver of epithelial ovarian cancer (EOC)] in combination with taxane and platinum therapy (C/P) in patients with recurrent platinum-sensitive ovarian cancer. With a standard 3 + 3 design, dose escalation started for IPA/C/P with q3w intravenous IPA on Day 1, in cycles 1 to 6 with C (AUC = 5 mg/ml·min) and P (175 mg/m2). They revised the trial to 6-patient cohorts with a q3w regimen of IPA on Day 1 and C/P on Day 3 (IPA → C/P) for enhanced bone safety. Treatment was provided to 37 patients; of these, 30 were treated following protocol revision to q3w IPA(D1) → C/P(D3) (2 & 4 mg/kg). The patients well tolerated IPA in combination with sequential C/P. Looking at historical data, this cohort showed comparable outcomes regarding overall response rate, PFS and OS; however, further development in EOC was limited by bone toxicity at efficacy doses of this particular Wnt inhibitor.
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