Spots Global Cancer Trial Database for Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
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Trial Identification
Brief Title: Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
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
Study ID: NCT01642082
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Florida Hospital Orlando, Orlando, Florida, United States
Sarasota Memorial Hospital, Sarasota, Florida, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford NCI Community Oncology Research Program of the North Central Plains, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Pacific Gynecology Specialists, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Northwest Hospital, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Contact Details
Name: Vicky Makker
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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