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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Hormone-receptor Positive Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

VEG108843

NCT ID:

NCT00615524

Start Date:

April 2008

Completion Date:

November 2012

Related Keywords:

  • Hormone-Receptor Positive Breast Cancer
  • Breast cancer
  • Advanced
  • Metastatic
  • Pazopanib
  • GW786034
  • Exemestane
  • Efficacy
  • Tolerability
  • Health-Related Quality of Life
  • Breast Neoplasms

Name

Location

GSK Clinical Trials Call Center Chula Vista, California  91911