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Burger RA , Deng W , Makker V , Collins Y , Gray H , Debernardo R , Martin LP , Aghajanian C
Phase II evaluation of dalantercept in the treatment of persistent or recurrent epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study
Gynecol Oncol. 2018 Sep;150(3) :466-470
PMID: 30041929 PMCID: PMC6546175 URL: https://www.ncbi.nlm.nih.gov/pubmed/30041929
AbstractOBJECTIVE: 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 1.2mg/kg every 3weeks until disease progression or development of unacceptable toxicity. The primary null hypothesis was the probability of response </=0.10 and the probability of 6-month progression-free survival without receipt of non-protocol therapy (event-free survival at 6months, EFS6) </=0.15, using RECIST 1.1 criteria. RESULTS: The first stage was closed after enrollment of 30 participants with median age of 56.5years, high-grade serous histology in 76.7%, 2 prior regimens in 46.7%, and platinum-free interval <6months 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 >/=4 AEs. There were no objective responses. EFS6 was reached in 20% (6 out of 30 participants, 90% CI 9.1% to 35.7%). CONCLUSIONS: Though safe, dalantercept as administered had limited efficacy in this patient population overall.
Notes1095-6859 Burger, Robert A Deng, Wei Makker, Vicky Collins, Yvonne Gray, Heidi Debernardo, Robert Martin, Lainie P Aghajanian, Carol Journal Article United States Gynecol Oncol. 2018 Sep;150(3):466-470. doi: 10.1016/j.ygyno.2018.06.017. Epub 2018 Jul 3.