Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer
Recruitment status was Active, not recruiting
RATIONALE: Brivanib alaninate 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.
PURPOSE: This phase II trial is studying how well brivanib alaninate works in treating patients with recurrent or persistent endometrial cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Brivanib (BMS582664), an Oral, Multitargeted Growth Factor Tyrosine Kinase Inhibitor in the Treatment of Recurrent or Persistent Endometrial Carcinoma|
- Frequency of patients with progression-free survival (PFS) for ≥ 6 months or objective tumor response [ Designated as safety issue: No ]
- Duration of progression-free survival (PFS) and overall survival [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by CTCAE v3.0 criteria [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
- To assess the activity of brivanib alaninate, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial carcinoma.
- To determine the duration of PFS and overall survival of these patients.
- To determine the nature and degree of toxicity of brivanib alaninate in these patients as assessed by CTCAE v3.0.
OUTLINE: This is a multicenter study.
Patients receive oral brivanib alaninate once daily 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 every 3 months for 2 years and then every 6 months for 3 years.