Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00110994

Purpose

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.

Condition	Intervention	Phase
Cancer Melanoma	Drug: Sorafenib (Nexavar, BAY43-9006) Drug: Placebo + Dacarbazine	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Dacarbazine Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy objective is to evaluate progression free survival (PFS) between subjects treated with sorafenib versus placebo in combination with DTIC [ Time Frame: 31 March 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events collection [ Time Frame: Until 30 days after last subject discontinues study treatment ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: Until occurence of 77th death ] [ Designated as safety issue: No ]
Tumor Response Rate [ Time Frame: Until occurence of 77th progression or death ] [ Designated as safety issue: No ]
Time to Progression [ Time Frame: Until occurence of 77th progression or death ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Until occurence of 77th progression or death ] [ Designated as safety issue: No ]
Change from Baseline in Performance Status [ Time Frame: Until occurence of 77th progression or death ] [ Designated as safety issue: No ]
Change from Baseline in EQ-5D Status [ Time Frame: Until occurence of 77th progression or death ] [ Designated as safety issue: No ]

Enrollment:	98
Study Start Date:	April 2005
Study Completion Date:	March 2008
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sorafenib (Nexavar, BAY43-9006) Multi Kinase Inhibitor: Sorafenib, 400 mg, 2 tablets (200 mg each) po bid Study days 1 - 21 + DTIC, 1000 mg/m2 IV on Study Day 1
Arm 2: Active Comparator	Drug: Placebo + Dacarbazine Placebo + Chemotherapy: Placebo, 2 tablets, po bid Study days 1 - 21 + DTIC, 1000 mg/m2 IV on Study Day 1

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, Tis & Ti) or any cancer curatively treated < 3 years prior to study entry
History of cardiac disease
Known history of human immunodeficiency virus (HIV) infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110994

Locations

United States, Arizona

Tucson, Arizona, United States, 85724
United States, Colorado

Denver, Colorado, United States, 80262
United States, Florida

Lakeland, Florida, United States, 33805
United States, Illinois

Park Ridge, Illinois, United States, 60068-1174
United States, Massachusetts

Boston, Massachusetts, United States, 02215

Boston, Massachusetts, United States, 02114-2696

Boston, Massachusetts, United States, 02115-6084
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Nebraska

Omaha, Nebraska, United States, 68114
United States, North Carolina

Charlotte, North Carolina, United States, 28203
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15213-2592
United States, South Carolina

Hilton Head Island, South Carolina, United States, 29926-2739
United States, Tennessee

Nashville, Tennessee, United States, 37232
United States, Texas

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	11715
Study First Received:	May 16, 2005
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00110994
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Sorafenib
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue

Enzyme Inhibitors
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Protein Kinase Inhibitors
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009