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

Official Title

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

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 tumour cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumour.

Trial Description

Primary Outcome:

  • Progression-free survival
  • Response rate
Secondary Outcome:
  • Baseline molecular status of archival tumour (c-met amplification and mutation status)
  • Overall survival
  • Pharmacodynamic responses in levels of soluble, circulating angiogenic factors
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 Tumours (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS). SECONDARY OBJECTIVES:
I. Correlation of clinical response with baseline molecular status of archival tumour (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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society