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

Phase 3

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: placebo; Drug: Sorafenib

• Registration Number: NCT00606866
• Lead Sponsor: University of Chicago

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 available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2007-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-05
• Study Completion: 2008-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I	placebo	placebo pill
II	Sorafenib	Sorafenib, 200 mg bid
III	Sorafenib	Sorafenib, 400 mg bid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To predict which patients are most likely to experience tumor shrinkage.	8 weeks

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States