MedTrace Logo

Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)

NCT00586105 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-04-16

Study results available
· View outcomes & findings →

Summary

A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (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
2005-12-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • China
  • Taiwan

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 NCT00586105 on ClinicalTrials.gov