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Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

NCT01189370 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-06-01

Study results available
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Summary

The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.

Conditions

  • Renal Cell Cancer

Interventions

DRUG

sorafenib

Dose Level: 1. 400mg twice daily, continuous. 2. 600mg twice daily, days 1-5 of each week. 3. 800mg twice daily, days 1-5 of each week.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Stephen Williamson, MD · The University of Kansas - Cancer Center

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT01189370 on ClinicalTrials.gov