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A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer
This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS). SECONDARY OBJECTIVES: I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor \[c-met\] amplification \& mutation status) and overall survival. OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Start Date
May 8, 2013
Primary Completion Date
September 12, 2019
Completion Date
October 24, 2024
Last Updated
October 1, 2025
102
ACTUAL participants
Cabozantinib S-malate
DRUG
Laboratory Biomarker Analysis
OTHER
Pharmacological Study
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT03660826
NCT02874430
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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