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A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

NCT00111007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2014-10-31

Study results available
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Summary

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

Conditions

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19

DRUG

Carboplatin/Paclitaxel

Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1

DRUG

Placebo

Placebo, 2 tablets bid Study Days 2-19

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-09-30
Completion
2009-01-31

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00111007 on ClinicalTrials.gov