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.

• Authors: Robert A Burger, Wei Deng, Vicky Makker, Yvonne Collins, Heidi Gray, Robert Debernardo, Lainie P Martin, Carol Aghajanian
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 150 Issue 3 Pg. 466-470 (09 2018) ISSN: 1095-6859 [Electronic] United States
• PMID: 30041929 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Antineoplastic Agents
• Immunoglobulin Fc Fragments
• Recombinant Fusion Proteins
• Activin Receptors, Type II
• ALK1-Fc fusion protein, human

Topics

• Activin Receptors, Type II (adverse effects, therapeutic use)
• Adult
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Carcinoma (drug therapy)
• Disease Progression
• Disease-Free Survival
• Fallopian Tube Neoplasms (drug therapy)
• Female
• Humans
• Immunoglobulin Fc Fragments (adverse effects, therapeutic use)
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Neoplasm, Residual
• Ovarian Neoplasms (drug therapy)
• Peritoneal Neoplasms (drug therapy)
• Recombinant Fusion Proteins (adverse effects, therapeutic use)
• Response Evaluation Criteria in Solid Tumors