check_circleStudy Completed

Cancer, Melanoma

Bayer Identifier:

11715

ClinicalTrials.gov Identifier:

NCT00110994

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment for Subjects with Unresectable Stage III or Stage IV Melanoma

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
101
Trial Dates
April 2005 - March 2008
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Vanderbilt University Medical SchoolNashville, 37232-6307, United States
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15232, United States
Completed
Beth Israel Deaconess Medical CenterBoston, 02215, United States
Completed
University of Arizona Cancer CenterTucson, 85724, United States
Completed
Dana-Farber Cancer InstituteBoston, 02115-6084, United States
Completed
Advocate Lutheran General HospitalPark Ridge, 60068, United States
Completed
University of Colorado Health Sciences CenterAurora, 80045, United States
Completed
South Carolina Cancer SpecialistsHilton Head Island, 29926-2739, United States
Completed
Nebraska Methodist HospitalOmaha, 68114, United States
Completed
Lakeland Regional Medical CenterLakeland, 33805, United States
Completed
Institute for Drug DevelopmentSan Antonio, 78229, United States
Completed
Carolinas Medical CenterCharlotte, 28203, United States
Completed
Washington University School of MedicineSt. Louis, 63110-1093, United States
Completed
Massachusetts General HospitalBoston, 02114, United States

Primary Outcome

  • Progression Free Survival (PFS)
    date_rangeTime Frame:
    Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Overall Survival (OS)
    date_rangeTime Frame:
    Time from randomization to death (the maximum treatment duration of 71.1 weeks)
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants in tumor response categories
    date_rangeTime Frame:
    Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression (TTP)
    date_rangeTime Frame:
    Time from randomization to documented tumor progression (median time of 148 days)
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response (DOR)
    date_rangeTime Frame:
    Time from initial response to documented tumor progression or death (median time of 188 days)
    enhanced_encryption
    Safety Issue:
    No
  • Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted
    date_rangeTime Frame:
    Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
    enhanced_encryption
    Safety Issue:
    No
  • Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment
    date_rangeTime Frame:
    Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
    enhanced_encryption
    Safety Issue:
    No
  • Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted
    date_rangeTime Frame:
    Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
    enhanced_encryption
    Safety Issue:
    No
  • Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment
    date_rangeTime Frame:
    Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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