Clinical Trial: Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: This phase II trial is studying how well brivanib alaninate works in treating patients with endometrial cancer that has come back (recurred) or is persistent. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the activity of brivanib (brivanib alaninate) for patients with recurrent or persistent endometrial cancer with the frequency of patients who survive progression-free for at least 6 months after initiating therapy or have objective tumor response..

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival. II. To determine the nature and degree of toxicity of brivanib as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 in this cohort of patients.

TERTIARY OBJECTIVES:

I. To determine whether activating mutations in fibroblast growth factor receptor 2 (FGFR2) are associated with progression-free survival status > 6 months following brivanib treatment, objective tumor response following brivanib treatment, or endometrioid histology.

II. To explore the associations between select biomarkers and response to brivanib (progression-free survival status > 6 months and objective tumor response), measures of clinical outcome (progression-free survival and overall survival) or disease status including histologic cell type: i) mutations in FGFR2 or phosphatase and tensin homolog (PTEN) in deoxyribonucleic acid (DNA) from formalin-fixed and paraffin-embedded (FFPE) tumor or normal blood cells; ii) immunohistochemical (IHC) expression of the FGFR family and ligands, steroid receptor isoforms or phosphorylated (p) v-akt murine thymoma viral oncogene homolog 1 (AKT) in FFPE tumor; iii) concentration or the change in the concentration of vascular endothelial growth factor (VEGF) or type IV collagen in pre-cycle 1, pre-cycle 2 and/o
Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Frequency of patients who survive progression-free for at least 6 months or have objectives tumor response [ Time Frame: 6 months ]

Original Primary Outcome: Frequency of patients with progression-free survival (PFS) for ≥ 6 months or objective tumor response

Current Secondary Outcome:

  • Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years ]
    Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on overall survival will be examined.
  • Duration of progression-free survival [ Time Frame: Form study entry until disease progression, death or date of last contact, assessed up to 5 years ]
    Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on progression-free survival will be examined.
  • Frequency of adverse effects defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment [ Time Frame: Up to 5 years ]
  • Severity of adverse events as assessed by CTCAE v3.0 criteria [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Duration of progression-free survival (PFS) and overall survival
  • Frequency and severity of adverse effects as assessed by CTCAE v3.0 criteria


Information By: Gynecologic Oncology Group

Dates:
Date Received: April 24, 2009
Date Started: July 2009
Date Completion:
Last Updated: March 16, 2016
Last Verified: March 2016