Phase IV Randomization to On-Going Treatment to Evaluate Sustained Sorafenib

NCT00352859 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-12-30

No results posted yet for this study

Summary

The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. More safety information on sorafenib will be also collected. About 260 patients with progressed renal cell cancer will be in this study.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon

Continue sorafenib with addition of gemcitabine or interferon

DRUG

Gemcitabine or Interferon (only)

Discontinue Sorafenib and receive Gemcitabine or Interferon only

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
2006-08-31
Completion
2006-11-30

Countries

  • United States

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 NCT00352859 on ClinicalTrials.gov