A Phase 2 interventional study of sorafenib tosylate and laboratory biomarker analysis in Epithelial Mesothelioma, Recurrent Malignant Mesothelioma and Sarcomatous Mesothelioma, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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.
470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.
This study's enrollment of 44 is close to the median of 40 across 371 interventional studies indexed under Mesothelioma.
Browse Mesothelioma studies →National Cancer Institute (NCI) is the lead sponsor of 3,505 studies on the registry; 333 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate · Other: laboratory biomarker analysis
Given orally
Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Correlative studies
Response rate (including complete and partial response)
The frequency of best response to the new treatment will be tabulated and the exact 95% binomial confidence intervals will be computed.
Time frame: Up to 3 years
Time to tumor progression
Described using the Kaplan Meier method.
Time frame: Up to 3 years
Percentage of patients remaining failure-free
Described using the Kaplan-Meier method.
Time frame: At 3 months
Overall survival
Described using the Kaplan-Meier method.
Time frame: Up to 3 year
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)