Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

ClinicalTrials.gov ID: NCT00110994

Public ClinicalTrials.gov record NCT00110994. 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.

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Official title

Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma

Brief summary

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

This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.

Study identification

NCT ID: NCT00110994
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Bayer; Industry
Enrollment: 101 participants

Conditions and interventions

Conditions

Interventions

Drug

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: Apr 2005 (Type not available)
Primary completion: Oct 2006 (Actual)
Completion: Mar 2008 (Actual)
Last update posted: Jun 8, 2015

2005 – 2008

United States locations

U.S. sites: 14
U.S. states: 12
U.S. cities: 12

Facility	City	State	ZIP	Site status
Not listed	Tucson	Arizona	85724	—
Not listed	Aurora	Colorado	80045	—
Not listed	Lakeland	Florida	33805	—
Not listed	Park Ridge	Illinois	60068	—
Not listed	Boston	Massachusetts	02114	—
Not listed	Boston	Massachusetts	02115-6084	—
Not listed	Boston	Massachusetts	02215	—
Not listed	St Louis	Missouri	63110-1093	—
Not listed	Omaha	Nebraska	68114	—
Not listed	Charlotte	North Carolina	28203	—
Not listed	Pittsburgh	Pennsylvania	15232	—
Not listed	Hilton Head Island	South Carolina	29926-2739	—
Not listed	Nashville	Tennessee	37232-6307	—
Not listed	San Antonio	Texas	78229	—

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

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00110994, 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 Jun 8, 2015 · Synced Nov 4, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00110994 live on ClinicalTrials.gov.

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