Trial Condition(s):
Cancer, Melanoma
Treatment for Subjects with Unresectable Stage III or Stage IV Melanoma
Bayer Identifier:
11715
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Vanderbilt University Medical School Nashville, United States, 37232-6307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pittsburgh Medical Center Health System Pittsburgh, United States, 15232 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beth Israel Deaconess Medical Center Boston, United States, 02215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arizona Cancer Center Tucson, United States, 85724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dana-Farber Cancer Institute Boston, United States, 02115-6084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advocate Lutheran General Hospital Park Ridge, United States, 60068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Colorado Health Sciences Center Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Carolina Cancer Specialists Hilton Head Island, United States, 29926-2739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nebraska Methodist Hospital Omaha, United States, 68114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeland Regional Medical Center Lakeland, United States, 33805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute for Drug Development San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Carolinas Medical Center Charlotte, United States, 28203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Washington University School of Medicine St. Louis, United States, 63110-1093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Massachusetts General Hospital Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression Free Survival (PFS)Timeframe: Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)
Secondary Outcome
- Overall Survival (OS)Timeframe: Time from randomization to death (the maximum treatment duration of 71.1 weeks)
- Number of participants in tumor response categoriesTimeframe: Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
- Time to Progression (TTP)Timeframe: Time from randomization to documented tumor progression (median time of 148 days)
- Duration of Response (DOR)Timeframe: Time from initial response to documented tumor progression or death (median time of 188 days)
- Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was NotedTimeframe: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
- Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First NotedTimeframe: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
- Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of TreatmentTimeframe: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
- Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First NotedTimeframe: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
- Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of TreatmentTimeframe: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Additional Information
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