DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hormone-receptor Positive Breast Cancer

Intervention: exemestane and pazopanib (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Progression free survival

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

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

Starting date: April 2008
Last updated: March 1, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017