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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT00606866
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
* At least one lesion that can be accurately measured in at least one dimension;
* Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
* Age 18 and older;
* ECOG performance status 0-2;
* Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
* Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
* Any other investigational agents;
* Known brain metastases;
* Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00606866
Study Brief:
Protocol Section:
NCT00606866