NCT00459862

Pazopanib in Treating Patients With Malignant Pleural Mesothelioma

Phase II Study of GW786034 in Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. 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 OBJECTIVES: I. Determine the effect of pazopanib hydrochloride on the proportion of patients with malignant pleural mesothelioma who are progression-free at 6 months based on the RECIST criteria. II. Determine the clinical toxicities of this drug in this patient population. SECONDARY OBJECTIVES: I. Determine the objective tumor response status in these patients as measured by the RECIST criteria or the modified RECIST criteria. II. Determine the response rate in patients treated with this drug. III. Determine the effect of this drug on overall survival and time to progression in these patients. IV. Assess predictive markers of activity of this drug in these patients. V. Assess serologic markers of target inhibition by this drug in these patients. VI. Determine the clinical toxicities of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Blood is collected at baseline and prior to each course of therapy and analyzed for markers of angiogenesis. After completion of study therapy, patients are followed every 3 months.

Conditions

• Advanced Malignant Mesothelioma
• Localized Malignant Mesothelioma
• Recurrent Malignant Mesothelioma

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative study
DRUG	pazopanib hydrochloride	Given orally

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-04-01
• Completion: 2013-05-01
• First posted: 2007-04-13
• Last updated: 2015-02-24
• Results posted: 2013-12-05

Locations

1 site across 1 country: United States