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BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

NCT00117637 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2014-10-31

Study results available
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Summary

The purpose of the study is to:

* Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
* Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression
* Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a
* Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage
* Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer
* Find out the level of BAY43-9006 in the blood once per month and any changes in this level
* Find out whether BAY43-9006 effects are associated with specific biomarkers

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Multi kinase inhibitor

DRUG

Interferon

Interferon

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-09-30
Completion
2009-03-31

Countries

  • United States
  • France
  • Germany
  • Poland
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00117637 on ClinicalTrials.gov