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An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients With Advanced Renal Cell Carcinoma

NCT00492986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1150

Last updated 2014-12-30

No results posted yet for this study

Summary

Purpose of the study:

The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.

Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.

Overall, participation in the study will help determine the following:

* Find out if patients receiving Sorafenib will live longer
* Find out if Sorafenib helps to slow the worsening of kidney cancer
* Find out if Sorafenib has an effect on the tumours

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Nexavar (Sorafenib, BAY43-9006)

Multikinase inhibitor: Sorafenib mono therapy 400 mg bid

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT00492986 on ClinicalTrials.gov