Clinical Trials Directory

Trials / Completed

CompletedNCT00131911

Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
93 (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 sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate 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 objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors. SECONDARY OBJECTIVES: I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival. OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated tumor). Each Group was independently evaluated for all study endpoints. Patients receive oral sorafenib tosylate 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 every 3 months until disease progression and then every 6 months for up to 2 years from study entry.

Conditions

Interventions

TypeNameDescription
DRUGsorafenib tosylate400 mg given orally

Timeline

Start date
2005-06-01
Primary completion
2010-10-01
Completion
2013-04-01
First posted
2005-08-19
Last updated
2014-11-17
Results posted
2014-11-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00131911. Inclusion in this directory is not an endorsement.