Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer

This study has been terminated.
(Cancelled Before Enrollment)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00615524
First received: February 1, 2008
Last updated: March 1, 2013
Last verified: March 2013

February 1, 2008
March 1, 2013
April 2008
November 2012   (final data collection date for primary outcome measure)
Progression free survival
Same as current
Complete list of historical versions of study NCT00615524 on ClinicalTrials.gov Archive Site
Safety and tolerability Overall response rate (complete and partial responses) in subjects with measurable disease Overall survival Change in health-related quality of life (HRQL) relative to baseline Biomarkers
Same as current
Not Provided
Not Provided
 
Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Compare the Efficacy and Tolerability of Pazopanib Administered in Combination With Exemestane Versus Exemestane Plus Placebo in Postmenopausal Subjects With Advanced or Metastatic Hormone Receptor Positive Breast Cancer

This study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with tamoxifen, anastrazole or letrozole.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hormone-receptor Positive Breast Cancer
Drug: exemestane and pazopanib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have measurable disease OR must be evaluable for disease progression
  • Age >/= 18 years.
  • Postmenopausal women
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Histologically or cytologically confirmed ER and/or PgR positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease
  • Subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen)
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • Prior use of exemestane or pazopanib
  • Premenopausal women
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
  • Prior therapy with a VEGF inhibitor.
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
  • Evidence of recurrence or active disease from prior malignancy.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding or affect the absorption of the investigational product(s).
  • Presence of uncontrolled infection.
  • History of any major cardiovascular conditions within the past 6 months:
  • Poorly controlled hypertension
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
  • Evidence of active bleeding or bleeding tendency.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00615524
VEG108843
Not Provided
Not Provided
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP