NCT01642082

Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endometrial Adenocarcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Mixed Adenocarcinoma
• Endometrial Mucinous Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Endometrial Squamous Cell Carcinoma
• Endometrial Transitional Cell Carcinoma
• Endometrial Undifferentiated Carcinoma
• Recurrent Uterine Corpus Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Dalantercept	Given SC
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-07-17
• Last updated: 2018-03-13
• Results posted: 2016-02-05

Locations

30 sites across 1 country: United States