Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Withdrawn before enrolling · Phase 2
Conditions studied: Hormone-receptor Positive Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00615524
- Run by
- GlaxoSmithKline
- People needed
- 0
- Starts
- 2008-04-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2018-01-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- GSK Clinical Trials Call Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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