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Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

Phase 3
18 Years
Not Enrolling
Metastatic Renal Cell Carcinoma

Thank you

Trial Information

Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

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

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

- Pregnancy.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib

Outcome Time Frame:

8 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

June 2008

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • renal, metastatic, carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



The University of ChicagoChicago, Illinois  60637