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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
  Purpose

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


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: placebo
Drug: Sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Chicago:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To predict which patients are most likely to experience tumor shrinkage. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: July 2004
Study Completion Date: June 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606866

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Bayer
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00606866     History of Changes
Other Study ID Numbers: 12977A
Study First Received: January 31, 2008
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Chicago:
renal, metastatic, carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014