NCT00509587

Pazopanib in Treating Patients With Recurrent or Metastatic Breast Cancer

A Phase 2 Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving pazopanib works in treating patients with recurrent or metastatic invasive breast cancer. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVE: I. To determine the antitumor activity of pazopanib, in terms of objective response rate (partial and complete response), in patients with recurrent or metastatic invasive breast cancer. SECONDARY OBJECTIVES: I. To determine the duration of objective response, rate and duration of stable disease. II. To determine 6-month progression-free and median and overall survival rates in patients treated with this drug. III. To document the safety and tolerability of this drug in these patients. OUTLINE: This is a multicenter, open label study. Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and at 1, 4, and 8 weeks for correlative laboratory studies. Blood samples are evaluated for the following tumor markers by ELISA: VEGF, bFGF, sFLT-1, sTIE-2, sE-Selectin, VCAM-1, PDGF-AA, PDGF-AB and PDGF-BB. TSP-1 in plasma is measured by Accucyte™ competitive immunoassay. After completion of study treatment, patients are followed every 3 months.

Conditions

• Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride	Given orally
PROCEDURE	pharmacological study	Correlative studies
PROCEDURE	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-07-01
• Completion: 2013-08-01
• First posted: 2007-07-31
• Last updated: 2018-08-08
• Results posted: 2016-12-14

Locations

3 sites across 1 country: Canada