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

November 27, 2023 updated by: University of Chicago

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: I
placebo pill
Drug: placebo
Placebo for four weeks
Active Comparator: II
Sorafenib, 200 mg bid
Drug: Sorafenib
Sorafenib, 400 mg twice daily
Drug: Sorafenib
Sorafenib 200 mg twice daily
Active Comparator: III
Sorafenib, 400 mg bid
Drug: Sorafenib
Sorafenib, 400 mg twice daily
Drug: Sorafenib
Sorafenib 200 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To predict which patients are most likely to experience tumor shrinkage.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimated)

February 5, 2008

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12977A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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