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

January 10, 2018 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression free survival

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEG108843

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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