MedDataX Logo

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

NCT ID: NCT00606866

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Renal Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I

placebo pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo for four weeks

II

Sorafenib, 200 mg bid

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Sorafenib 200 mg twice daily

III

Sorafenib, 400 mg bid

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Sorafenib, 400 mg twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo

Placebo for four weeks

Intervention Type DRUG

Sorafenib

Sorafenib 200 mg twice daily

Intervention Type DRUG

Sorafenib

Sorafenib, 400 mg twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12977A

Identifier Type: -

Identifier Source: org_study_id