NCT00796861

Trial of Sunitinib for Refractory Malignant Ascites

Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ascites

Interventions

Type	Name	Description
DRUG	Sunitinib	Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-11-24
• Last updated: 2017-12-20
• Results posted: 2017-12-20

Locations

1 site across 1 country: United States