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