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Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

NCT00073307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 903

Last updated 2014-02-06

Study results available
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Summary

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Multi Kinase Inhibitor

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2006-09-30
Completion
2010-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00073307 on ClinicalTrials.gov