Last updated: 11/04/2018 13:29:30
Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer
GSK study ID
VEG108843
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
hormone-receptor positive breast cancer
Product
pazopanib
Collaborators
Not applicable
Study date(s)
June 2008 to July 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Subjects must have measurable disease OR must be evaluable for disease progression
- Age >/= 18 years.
- Prior use of exemestane or pazopanib
- Premenopausal women
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Clinical Trials Call Center
San Francisco, CA, United States, 94115
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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