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

   

Authors:	Burger, R. A.; Deng, W.; Makker, V.; Collins, Y.; Gray, H.; Debernardo, R.; Martin, L. P.; Aghajanian, C.
Article Title:	Phase II evaluation of dalantercept in the treatment of persistent or recurrent epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study
Abstract:	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 ≤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 ≥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. © 2018 Elsevier Inc.
Keywords:	clinical trial; ovarian cancer; phase ii; dalantercept
Journal Title:	Gynecologic Oncology
Volume:	150
Issue:	3
ISSN:	0090-8258
Publisher:	Elsevier Inc.
Date Published:	2018-09-01
Start Page:	466
End Page:	470
Language:	English
DOI:	10.1016/j.ygyno.2018.06.017
PROVIDER:	scopus
PUBMED:	30041929
PMCID:	PMC6546175
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-85049330484&doi=10.1016%2fj.ygyno.2018.06.017&partnerID=40&md5=a97f21b2f269ad3499666a44e1d88e89
Notes:	Article -- Export Date: 4 September 2018 -- Source: Scopus

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