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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.

Author information

1
Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, United States. Electronic address: makkerv@mskcc.org.
2
NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
3
Obstetrics and Gynecology, University of California, San Francisco, San Francisco, CA 94115, United States.
4
Gynecologic Oncology, Maine Medical Center, Scarborough, ME 04074, United States.
5
Gynecologic Oncology, Florida Hospital Cancer Institute Orlando, FL 32804, United States.
6
Gynecologic Oncology, St. Vincent Hospitals and Health Services, Indianapolis, IN 46269, United States.
7
Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States.
8
Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, United States.

Abstract

OBJECTIVE:

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

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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

KEYWORDS:

ALK-1; Dalantercept; Recurrent endometrial cancer

PMID:
25888978
PMCID:
PMC4615687
DOI:
10.1016/j.ygyno.2015.04.006
[Indexed for MEDLINE]
Free PMC Article

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