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
DOI/URL:
Notes: Article -- Export Date: 4 September 2018 -- Source: Scopus
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  1. Vicky Makker
    86 Makker