Status:
COMPLETED
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Bayer
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00606866
Start Date
July 1 2004
End Date
June 1 2008
Last Update
November 29 2023
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637