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

NCT00615524 | Withdrawn Phase 2

• 1 other identifier: VEG108843
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hormone-receptor Positive Breast Cancer

Keywords

Breast cancer; Advanced; Metastatic; Pazopanib; GW786034; Exemestane; Efficacy; Tolerability; Health-Related Quality of Life

Outcome Measures

Primary Outcomes (1)

• Progression free survival

Secondary Outcomes (1)

• 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

Interventions

exemestane and pazopanib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Clinical Trials Call Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

exemestane; pazopanib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)