Phase II Study Evaluating Exemestane Alone Or In Combination With Pazopanib In Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Hormone-receptor Positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00615524
• Other study ID #: VEG108843
• Status: Withdrawn
• Phase: Phase 2
• First received: February 1, 2008
• Last updated: January 10, 2018
• Start date: April 2008
• Est. completion date: November 2012

Study information

• Verified date: January 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone-receptor Positive Breast Cancer

Intervention

Drug:
• exemestane and pazopanib

Locations

Country	Name	City	State
United States	GSK Clinical Trials Call Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival
Secondary	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