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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Metastatic Renal Cell Carcinoma	Drug: placebo; Drug: Sorafenib	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	57 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Study Start Date :	July 2004
Actual Primary Completion Date :	January 2007
Actual Study Completion Date :	June 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. To predict which patients are most likely to experience tumor shrinkage. [ Time Frame: 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Bayer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00606866 History of Changes
Other Study ID Numbers:	12977A
First Posted:	February 5, 2008
Last Update Posted:	March 27, 2014
Last Verified:	March 2014

Keywords provided by University of Chicago:

renal, metastatic, carcinoma

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Renal Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases	Sorafenib; Niacinamide; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs