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

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00606866
• Collaborator: Bayer (Industry)
• Enrollment: 57
• Location: 1
• Arms: 3
• Duration (Months): 47
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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; Drug: Sorafenib	Phase 3

Study Design

• Study Type: Interventional
• 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: Jul 1, 2004
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

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

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 [8 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00606866
• Other Study ID Numbers: 12977A
• First Posted: Feb 5, 2008
• Last Update Posted: Mar 27, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by University of Chicago: renal, metastatic, carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell; Sorafenib

Study Results

No Results Posted as of Mar 27, 2014