Trial of Sunitinib for Refractory Malignant Ascites

Stopped early · Phase 2

Conditions studied: Ascites

In brief

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

Key facts

Study ID

NCT00796861

Run by

Milton S. Hershey Medical Center

People needed

4

Starts

2007-05-01

Expected to finish

2011-04-01

Last updated by the study team

2017-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or the inability to receive standard treatment due to performance status (PS>2).
• Ascites based on paracentesis or CT scan within one month prior to enrollment
• Life expectancy > 3 months
• Indwelling paracentesis catheters are permitted, paracentesis is permitted at the investigators discretion
• Negative urine pregnancy test for females
• All subjects must agree to use birth control
• All subjects must abstain from eating grapefruit and grapefruit juice. They must tell their physicians about any changes in their medication including over-the-counter and herbal supplements.

You may not qualify if…

• History of congestive heart failure
• Creatinine > 2.0
• Pregnant or nursing
• ALT > 2.5 times the upper limit of normal
• Blood pressure > 160/90 (antihypertensives permitted)
• Gastrointestinal or intra-abdominal hemorrhage within the last 6 months
• History of QTc > 450 milliseconds
• Brain metastasis

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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