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 Jul 25, 2019
Moore KN, et al. - Through a phase Ib trial, the researchers ascertained the maximum tolerated dose (MTD) and recommended phase 2 dose for ipafricept (IPA) in combination with taxane and platinum therapy (C/P). Thirty-seven cases were treated out of which 30 were treated after the protocol revision to q3w IPA(D1) → C/P(D3). Fatigue, nausea, diarrhea and decreased appetite each, dysgeusia and vomiting were IPA-related TEAEs that were observed in ≥15%. Nearly 22% reported ≥1 IPA related TEAE Grade ≥3 with neutropenia as the most prevalent at 16%. There were no DLTs and the MTD was not reached. On the basis of bone safety, the maximum administered dose was 6 mg/kg. The overall response rate (ORR) was estimated to be 75.7%. Median PFS and OS were 10.3 months and 33 months, respectively. Hence, in combination with sequential C/P, IPA was well endured. Moreover, ORR, PFS, and OS were comparable to historical data however, bone toxicity at efficiency doses of this particular Wnt inhibitor restricted further development in epithelial ovarian cancer.
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