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

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

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

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: placebo
* Drug: Sorafenib
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I<br>placebo pill | Drug: placebo<br>* Placebo for four weeks<br>|
| Active Comparator: II<br>Sorafenib, 200 mg bid | Drug: Sorafenib<br>* Sorafenib 200 mg twice daily<br>|
| Active Comparator: III<br>Sorafenib, 400 mg bid | Drug: Sorafenib<br>* Sorafenib, 400 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether a new experimental MRI technique called Dynamic Contrast Enhanced MRI (DCE-MRI) can determine the best dose of sorafenib |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To predict which patients are most likely to experience tumor shrinkage. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal, metastatic, carcinoma