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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00606866
First received: January 31, 2008
Last updated: March 26, 2014
Last verified: March 2014

January 31, 2008
March 26, 2014
July 2004
January 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606866 on ClinicalTrials.gov Archive Site
To predict which patients are most likely to experience tumor shrinkage. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
  • Drug: placebo
    Placebo for four weeks
  • Drug: Sorafenib
    Sorafenib 200 mg twice daily
  • Drug: Sorafenib
    Sorafenib, 400 mg twice daily
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
June 2008
January 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606866
12977A
Yes
University of Chicago
University of Chicago
Bayer
Not Provided
University of Chicago
March 2014

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