A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC)
Intervention description: Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid)
Intervention MeSH terms: Sorafenib; Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY
      43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC).
      DTIC is the current standard chemotherapy drug given for melanoma that has spread through the
      body. Although this drug can be effective on its own and is generally well tolerated, not all
      patients will benefit, so there is a need to test new drugs and drug combinations for
      treating melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with advanced, metastatic, histologically confirmed melanoma, for whom
             treatment with dacarbazine is considered medically acceptable

          -  Age >= 18 years

          -  Subject has measurable and evaluable disease defined as at least one metastatic lesion
             that can be accurately and serially measured by Computed Tomography (CT) or Magnetic
             Resonance Imaging (MRI) scan as per the Response Evaluation Criteria in Solid Tumors
             (RECIST) criteria. Cutaneous lesions measuring at least 20mm in longest diameter can
             be considered measurable (and therefore target lesions) via color photography
             including a ruler

          -  Subject has biopsiable disease at baseline and is willing to provide biopsy samples,
             or does not have biopsiable disease at baseline

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

        Exclusion Criteria:

          -  Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted)

          -  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 & T1] or any cancer curatively
             treated > 3 years prior to study entry

          -  (Active coronary artery disease or ischemia (myocardial infarction more than 6 months
             prior to study entry is allowed)

          -  Uncontrolled hypertension (> grade 2 National Cancer Institute - Common Terminology
             Criteria for Adverse Events (NCI-CTCAE) version 3.0)

          -  Active, clinically serious infections (> grade 2 NCI-CTCAE version 3.0)

          -  Subjects with seizure disorder requiring medication are excluded

          -  History of or suspected Human Immunodeficiency Virus (HIV) infection, or chronic
             hepatitis B or C

          -  Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from
             definitive therapy, has a negative imaging study within 4 weeks prior to study entry
             and is clinically stable with respect to the tumor at the time of study entry. Also
             the subject must not be undergoing acute steroid therapy or taper (chronic steroid
             therapy is acceptable provided that the dose is stable for one month prior to and
             following screening radiographic studies)

          -  Pregnant or breast-feeding subjects