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

Metastatic Renal Cell Carcinoma Clinical Trial

— MRI  

Official title:

Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606866
• Other study ID #: 12977A
• Status: Completed
• Phase: Phase 3
• Start date: July 2004
• Est. completion date: June 2008

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• placebo
Placebo for four weeks
• Sorafenib
Sorafenib 200 mg twice daily
• Sorafenib
Sorafenib, 400 mg twice daily

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib		8 weeks
Secondary	To predict which patients are most likely to experience tumor shrinkage.		8 weeks