Phase II evaluation of dalantercept in the treatment of persistent or recurrent epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study

Objective. To determine the efficacy of dalantercept, a soluble ALK1 inhibitor receptor fusion protein, in patients with persistent or recurrent ovarian carcinoma and related malignancies. Methods. Eligibility criteria included measurable disease, 1-2 prior cytotoxic regimens and GOG performance status (PS) <= 2. Dalantercept was administered subcutaneously at 1.2 mg/kg every 3 weeks until disease progression or development of unacceptable toxicity. The primary null hypothesis was the probability of response 5.0.10 and the probability of 6-month progression-free survival without receipt of non-protocol therapy (event-free survival at 6 months, EFS6) <= 0.15, using RECIST 1.1 criteria. Results. The first stage was closed after enrollment of 30 participants with median age of 56.5 years, high-grade serous histology in 76.7%, 2 prior regimens in 46.7%, and platinum-free interval <6 months in 73.3%. All participants discontinued dalantercept, 24 (80.0%), 5 (16.7%) and 1 (3.3%) due to progression, toxicity, and other reason, respectively. The median number of treatment cycles per patient was 2 (range 1-29). There were six treatment-related grade 3 AEs and no grade >= 4AEs. There were no objective responses. EFS6 was reached in 20% (6 out of 30 participants, 90% Cl 9.1% to 35.7%). Conclusions. Though safe, dalantercept as administered had limited efficacy in this patient population overall. (C) 2018 Elsevier Inc. All rights reserved.