MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Bayer
• Treatments: Niacinamide; Sorafenib

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.