MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma (MRI)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00606866 |
Recruitment Status :
Completed
First Posted : February 5, 2008
Last Update Posted : March 27, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Renal Cell Carcinoma | Drug: placebo Drug: Sorafenib | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: I
placebo pill
|
Drug: placebo
Placebo for four weeks |
Active Comparator: II
Sorafenib, 200 mg bid
|
Drug: Sorafenib
Sorafenib 200 mg twice daily |
Active Comparator: III
Sorafenib, 400 mg bid
|
Drug: Sorafenib
Sorafenib, 400 mg twice daily |
- To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib [ Time Frame: 8 weeks ]
- To predict which patients are most likely to experience tumor shrinkage. [ Time Frame: 8 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606866
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00606866 |
Other Study ID Numbers: |
12977A |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | March 27, 2014 |
Last Verified: | March 2014 |
renal, metastatic, carcinoma |
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Sorafenib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |