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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Progression-free survival [ Time Frame: Time from start of treatment to time of progression or death, assessed at 12 weeks ]
    Defined as the percentage of patients progression free 12 weeks from starting treatment.
  • Response rate [ Time Frame: Up to 12 weeks post-treatment ]
    Assessed using Response Evaluation Criteria in Solid Tumors version 1.1.


Original Primary Outcome:

  • Response rate (RR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 12 weeks post-treatment ]
  • Progression-free survival (PFS) [ Time Frame: Time from start of treatment to time of progression or death, assessed at 12 weeks ]


Current Secondary Outcome:

  • Baseline molecular status of archival tumor (c-met amplification and mutation status) [ Time Frame: Baseline ]
    Will correlate with clinical response.
  • Overall survival [ Time Frame: Time from start of treatment to time of death, assessed up to 4 years ]
    Will correlate with clinical response.
  • Pharmacodynamic responses in levels of soluble, circulating angiogenic factors [ Time Frame: Baseline and day 1 of course 2 ]
    Will correlate with clinical response.


Original Secondary Outcome:

  • Baseline molecular status of archival tumor (c-met amplification & mutation status) [ Time Frame: Baseline ]
  • Pharmacodynamic responses in levels of soluble, circulating angiogenic factors [ Time Frame: Baseline; day 1 of all courses ]


Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 3, 2013
Date Started: April 2013
Date Completion:
Last Updated: May 25, 2017
Last Verified: March 2017