Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study

Exclusion Criteria

• •Treatment with other UV sensitizing compounds such as psoralens, phenothiazine, tetracycline, amiodarone, phytopharmacons
• •UV treatment within the last 3 months
• •Previous treatment with a BRAF and/or MEK inhibitor.
• •Cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of an investigational anti-cancer drug within 28 days preceding the first dose of dabrafenib or vemurafenib
• •Current use of a prohibited medication or requires any of these medications during treatment with dabrafenib or vemurafenib
• •Current use of therapeutic warfarin NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted
• •Unresolved toxicity of National Cancer Institute Common (NCI) Terminology Criteria for Adverse Events, v 4.0, ( Grade 2 or higher from previous anti-cancer therapy, except alopecia
• •Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs
• •A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
• •Known immediate or delayed hypersensitivity reaction to Vemurafenib or Dabrafenib or excipients
• •Presence of non-cutaneous malignancies other than metastatic melanoma (Stage IV) within 5 years of study enrollment or any malignancy with confirmed activating RAS mutation
• •Brain metastases that are symptomatic and/or requiring corticosteroids. Subjects on a stable dose of corticosteroids \>1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for \>4 weeks
• •Corrected QT (QTc) interval \>450 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; abnormal cardiac valve morphology (≥ grade 2) documented by echocardiogram (subjects with minimal abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study with approval from the coordinating Investigator; or history of known cardiac arrhythmias
• •Uncontrolled dysfunction of the electrolyte metabolism
• •Known Long-QT-syndrome or intake of drugs which prolong the QT interval
• •Uncontrolled medical conditions (i.e., diabetes mellitus, hypertension, etc.), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol
• •Patients with extensive tattoos that would restrict skin surface available for phototesting or obscure skin reactions
• •Pregnant or lactating females