Endometrial Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of Dalantercept, a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Recurrent or Persistent Endometrial Carcinoma
This phase II trial studies how well dalantercept works in treating patients with endometrial cancer that has come back or is persistent. Dalantercept may stop the growth of endometrial cancer by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients with persistent or recurrent endometrial cancer who
survive progression-free for at least 6 months and the proportion of patients who have
objective tumor response (complete or partial), treated with dalantercept (ACE-041).
II. To determine the nature and degree of toxicity of dalantercept in this cohort of
patients.
SECONDARY OBJECTIVES:
I. To estimate progression-free survival (PFS) and overall survival (OS) of patients with
persistent or recurrent endometrial cancer treated with dalantercept.
TERTIARY OBJECTIVES:
I. To measure the expression of vascular endothelial growth factor (VEGF), fibroblast growth
factor (FGF), platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β),
activin receptor-like kinase 1 (ALK1), endoglin (CD105), and other markers via
immunohistochemistry (IHC) and determine if there is correlation between expression and
clinical response to treatment.
II. To determine the correlation between ALK1 gene expression, other markers, and clinical
response to treatment.
III. To determine the correlation between concentration of VEGF, bone morphogenetic protein 9
(BMP9), bone morphogenetic protein 10 (BMP10), and ALK1 in pre-cycle 1 plasma using an
enzyme-linked immunosorbent assay (ELISA), and clinical response to treatment.
IV. To correlate somatic mutations in candidate genes with response to therapy.
OUTLINE:
Patients receive dalantercept subcutaneously (SC) on day 1. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
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