Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT00796861
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00796861
Study Brief:
Protocol Section:
NCT00796861