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Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Endometrial Serous Adenocarcinoma Clinical Trial

Official title:
A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01935934
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 29, 2013
Completion date March 26, 2025
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