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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT00193258
Eligibility Criteria:
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy
* Previous nephrectomy is required
* Maximum of 1 previous systemic regimen for metastatic disease.
* Able to perform activities of daily living with minimal assistance
* Measurable disease
* Adequate bone marrow, liver and kidney
* Written informed consent.
Exclusion Criteria:
* Age \< 18 years
* Treatment with more than 1 previous systemic regimen
* History of heart attack within 6 months
* Clinically significant cardiovascular disease
* Moderate to severe vascular disease.
* Active brain metastases.
* History or evidence by physical examination of brain tumor
* Seizures not controlled with standard medical therapy
* history of stroke or other serious disorders of the nervous system
* Clinical history of coughing or vomiting blood within the past 3 months.
* PEG tubes or G tubes
* Chronic therapy with NSAIDS or other platelet inhibitors
* Proteinuria
* Nonhealing wound, ulcer, or long bone fracture
* Clinical evidence or history of a bleeding disorder
* Requiring full dose anticoagulation with coumadin
* Receiving chronic steroid therapy
* Significant medical conditions.
* Tumors other than clear cell
* History of stroke within 6 months.
* History of abdominal fistula,perforation,or abscess within 6 months.
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00193258
Study Brief:
Protocol Section:
NCT00193258