Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00107432
Brief Summary:
This phase II trial is studying how well sorafenib works in treating patients with malignant mesothelioma. Sorafenib 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. To determine the response rate (partial response (PR) and complete response (CR)) in patients with malignant mesothelioma treated with BAY 43-9006.
SECONDARY OBJECTIVES:
I. To determine 3-month failure free survival in patients with malignant mesothelioma treated with BAY 43-9006.
II. To describe the median and overall survival of malignant mesothelioma patients treated with BAY 43-9006.
III. To describe the toxicity profile of BAY 43-9006 in patients with malignant mesothelioma.
IV. To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf gene and correlate these findings with anti-tumor activity of BAY 43-9006.
V. To determine whether the amount of expression of phospho-ERK1/2, as determined by immunohistochemistry from pre-treatment tumor specimens, correlates with anti-tumor activity of BAY 43-9006 in patients with mesothelioma.
VI. To determine whether baseline levels and changes following BAY 43-9006 treatment in angiogenic cytokines (VEGF and PDGF) correlate with anti-tumor activity of BAY 43-9006.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
Study:
NCT00107432
Study Brief:
Protocol Section:
NCT00107432