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

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
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date March 27, 2014
Study Start Date  ICMJE July 2004
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
To predict which patients are most likely to experience tumor shrinkage. [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Official Title  ICMJE Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Brief Summary The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: placebo
    Placebo for four weeks
  • Drug: Sorafenib
    Sorafenib 200 mg twice daily
  • Drug: Sorafenib
    Sorafenib, 400 mg twice daily
Study Arms  ICMJE
  • Placebo Comparator: I
    placebo pill
    Intervention: Drug: placebo
  • Active Comparator: II
    Sorafenib, 200 mg bid
    Intervention: Drug: Sorafenib
  • Active Comparator: III
    Sorafenib, 400 mg bid
    Intervention: Drug: Sorafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2008)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606866
Other Study ID Numbers  ICMJE 12977A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Bayer
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP