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Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

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

NCT00110994•Bayer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who have a life expectancy of at least 12 weeks
•Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
•Patients who have an ECOG PS of 0, or 1
•Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria

Exclusion Criteria

•Primary ocular or mucosal melanoma
•Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry
•History of cardiac disease
•Known history of human immunodeficiency virus (HIV) infection

Locations (14)

Tucson, Arizona, United States

Aurora, Colorado, United States

Lakeland, Florida, United States

Park Ridge, Illinois, United States

Boston, Massachusetts, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Charlotte, North Carolina, United States

Key Dates

Start Date

April 1, 2005

Primary Completion Date

October 1, 2006

Completion Date

March 1, 2008

Last Updated

June 8, 2015

Enrollment

101

ACTUAL participants

Conditions

CancerMelanoma

Interventions

Sorafenib (Nexavar, BAY43-9006)

DRUG

Placebo

DRUG

Dacarbazine

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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