Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Melanoma
Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug); Dacarbazine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Progression Free Survival (PFS)
Secondary outcome: Overall Survival (OS)Number of Participants in Tumor Response Categories Time to Progression (TTP) Duration of Response (DOR) Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 [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 and Contacts
Tucson, Arizona 85724, United States
Aurora, Colorado 80045, United States
Lakeland, Florida 33805, United States
Park Ridge, Illinois 60068, United States
Boston, Massachusetts 02114, United States
Boston, Massachusetts 02115-6084, United States
Boston, Massachusetts 02215, United States
St. Louis, Missouri 63110-1093, United States
Omaha, Nebraska 68114, United States
Charlotte, North Carolina 28203, United States
Pittsburgh, Pennsylvania 15232, United States
Hilton Head Island, South Carolina 29926-2739, United States
Nashville, Tennessee 37232-6307, United States
San Antonio, Texas 78229, United States
Additional Information
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Starting date: April 2005
Last updated: May 13, 2015
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