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)
Information provided by:
First received: February 1, 2008
Last updated: March 1, 2013
Last verified: March 2013
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.
Hormone-receptor Positive Breast Cancer
Drug: exemestane and pazopanib
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615524
|GSK Clinical Trials Call Center
|San Francisco, California, United States, 94115 |
||GSK Clinical Trials, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 1, 2008
||March 1, 2013
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Health-Related Quality of Life
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 14, 2014
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action