Back to resultsMRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma (MRI)
Primary Purpose
Metastatic Renal Cell Carcinoma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
placebo
Sorafenib
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring renal, metastatic, carcinoma
Eligibility 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.
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
I
II
III
Arm Description
placebo pill
Sorafenib, 200 mg bid
Sorafenib, 400 mg bid
Outcomes
Primary Outcome Measures
To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib
Secondary Outcome Measures
To predict which patients are most likely to experience tumor shrinkage.
Full Information
NCT ID
NCT00606866
First Posted
January 31, 2008
Last Updated
March 26, 2014
Sponsor
University of Chicago
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00606866
Brief Title
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Acronym
MRI
Official Title
Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
renal, metastatic, carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Placebo Comparator
Arm Description
placebo pill
Arm Title
II
Arm Type
Active Comparator
Arm Description
Sorafenib, 200 mg bid
Arm Title
III
Arm Type
Active Comparator
Arm Description
Sorafenib, 400 mg bid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo for four weeks
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib 200 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib, 400 mg twice daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To predict which patients are most likely to experience tumor shrinkage.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
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