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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00111007

Public ClinicalTrials.gov record NCT00111007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 1:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00111007
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
270 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2005 (Type not available)
Primary completion
Sep 2006 (Actual)
Completion
Jan 2009 (Actual)
Last update posted
Oct 31, 2014

2005 – 2009

United States locations

U.S. sites
19
U.S. states
17
U.S. cities
19
Facility City State ZIP Site status
Not listed Birmingham Alabama 35243 —
Not listed Tucson Arizona 85724 —
Not listed Los Angeles California 90025 —
Not listed Aurora Colorado 80045 —
Not listed Tampa Florida 33612 —
Not listed Chicago Illinois 60612 —
Not listed Park Ridge Illinois 60068 —
Not listed Louisville Kentucky 40202 —
Not listed St Louis Missouri 63110 —
Not listed Omaha Nebraska 68114 —
Not listed Montclair New Jersey 07042 —
Not listed Buffalo New York 14263 —
Not listed New York New York 10065 —
Not listed Columbus Ohio 43221 —
Not listed Pittsburgh Pennsylvania 15232 —
Not listed Nashville Tennessee 37232-6307 —
Not listed Houston Texas 77030 —
Not listed Charlottesville Virginia 22908 —
Not listed Seattle Washington 98109-1023 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00111007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 31, 2014 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00111007 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →