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Gynecol Oncol. 2015 Jul;138(1):24-9. doi: 10.1016/j.ygyno.2015.04.006. Epub 2015 Apr 16.

Phase II evaluation of dalantercept, a soluble recombinant activin receptor-like kinase 1 (ALK1) receptor fusion protein, for the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group Study 0229N.

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Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, United States. Electronic address:
NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
Obstetrics and Gynecology, University of California, San Francisco, San Francisco, CA 94115, United States.
Gynecologic Oncology, Maine Medical Center, Scarborough, ME 04074, United States.
Gynecologic Oncology, Florida Hospital Cancer Institute Orlando, FL 32804, United States.
Gynecologic Oncology, St. Vincent Hospitals and Health Services, Indianapolis, IN 46269, United States.
Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States.
Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, United States.



This two-stage phase II study assessed activity of single agent dalantercept in patients with recurrent/persistent endometrial carcinoma (EMC).


Eligible patients had persistent/recurrent EMC after 1-2 prior cytotoxic regimens, measurable disease (RECIST 1.1), and GOG performance≤2. Dalantercept 1.2mg/kg subcutaneous was administered once every 3weeks until disease progression (PD)/development of prohibitory toxicity. Primary objectives were to estimate the proportion of patients with persistent/recurrent EMC, who survive progression-free without receiving non-protocol therapy (TPFS) for at least 6months and to estimate the proportion having objective tumor response.


All 28 enrolled patients were eligible and evaluable. Median age: 62years. Most common histologies: 32% Grade 1/2 endometrioid and 54% serous tumors. Prior treatment: 1 or 2 regimens in 82% and 18% of patients, respectively. Eighteen patients received prior radiation therapy. Patients received 1-12 cycles of dalantercept, and 46% of patients received ≤2cycles. The most common adverse events (AE) were fatigue, anemia, constipation and peripheral edema. Grade 3/4 AEs occurred in 39% and 4% of patients. One grade 5 gastric hemorrhage in a patient with a history of radiation fibrosis/small bowel obstruction was deemed possibly dalantercept-related. All patients are off study: 86% for PD. No ORs were observed; 57% had stable disease and 11% had TPFS>6 mos. Median progression-free and overall survival: 2.1months (90% CI: 1.4-3.2) and 14.5months (90% CI: 7.0-17.5), respectively.


Dalantercept has insufficient single agent activity in recurrent EMC to warrant further investigation at this dose level and schedule.


ALK-1; Dalantercept; Recurrent endometrial cancer

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