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Trial of Sunitinib for Refractory Malignant Ascites

Ascites Clinical Trial

Official title:
Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

Clinical Trial Summary

The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

Clinical Trial Description

This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00796861
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Terminated
Phase Phase 2
Start date May 2007
Completion date April 2011
View Details
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