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Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

NCT00079612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2014-12-19

No results posted yet for this study

Summary

The purpose of the study is to:

* Find out if BAY 43-9006 prevents the growth of tumors
* For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
* Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
* Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

800mg daily (2x 400mg tabs)

DRUG

Placebo

2x 400mg tabs daily

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Completion
2007-01-31

Countries

  • United States
  • 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 NCT00079612 on ClinicalTrials.gov