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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.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00615524
  Purpose

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.


Condition Intervention Phase
Hormone-Receptor Positive Breast Cancer
Drug: exemestane and pazopanib
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Exemestane Pazopanib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Progression free survival

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: April 2008
Estimated Study Completion Date: July 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615524

Locations
United States, California
GSK Clinical Trials Call Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Study ID Numbers: VEG108843
Study First Received: February 1, 2008
Last Updated: August 5, 2008
ClinicalTrials.gov Identifier: NCT00615524  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Breast cancer
Advanced
Metastatic
Pazopanib
GW786034
Exemestane
Efficacy
Tolerability
Health-Related Quality of Life

Study placed in the following topic categories:
Skin Diseases
Quality of Life
Breast Neoplasms
Exemestane
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009