Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- PFS [ Time Frame: From study entry to time of progression or death, assessed up to 6 months ] [ Designated as safety issue: No ]
- Objective tumor response (complete or partial response) as measured by RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- PFS [ Time Frame: From study entry to time of progression or death, assessed up to 5 years ] [ Designated as safety issue: No ]
- OS [ Time Frame: From study entry to time of death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
- Adverse events, as assessed by the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (dalantercept)
Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
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) when treated with dalantercept.
II. To determine the nature and degree of toxicity of dalantercept in this cohort of patients.
I. To estimate progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with dalantercept.
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: This is a multicenter study.
Patients receive dalantercept subcutaneously (SC) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected for VEGF, FGF, PDGF, TGF-β, ALK1, CD105, ALK1, BMP9, and BMP10 protein analysis and gene expression by IHC, ELISA, and reverse transcriptase polymerase chain reaction (RT-PCR).
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642082
Show 32 Study Locations
|Principal Investigator:||Vicky Makker||Gynecologic Oncology Group|