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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Issues on "Safety" outcomes are addressed in the Adverse Event section.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
