A Pilot Study of Trientine With Vemurafenib for the Treatment BRAF Mutated Metastatic Melanoma

Exclusion Criteria

• •1. Prior treatment with a BRAF or MEK inhibitor for metastatic melanoma (treatment in the adjuvant setting is allowed)
• •2. Any other malignancy form which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or DCIS. Patients with prior malignancies that are not considered to be an active problem may be enrolled at the discretion of the investigator, regardless of time frame.
• •3. Women of childbearing potential (WOCBP), defined above in Section 4.1, who:
• •1. are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or
• •2. have a positive pregnancy test at baseline, or
• •3. are pregnant or breastfeeding.
• •4. Anti-cancer therapy within 28 days prior to starting on therapy
• •5. Any serious or unstable pre-existing medical conditions psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.
• •6. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed).
• •7. A history or evidence of cardiovascular risk including any of the following:
• •1. A QTc interval ≥ 500 ms at screening
• •2. A history or evidence of current clinically significant uncontrolled arrhythmias; Exception: Subjects with atrial fibrillation controlled for \> 30 days prior to randomization are eligible.
• •3. A history (within 6 months prior to randomization) of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty
• •4. A history or evidence of current ≥Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines
• •5. Treatment refractory hypertension defined as a blood pressure of systolic\> 150 mmHg and/or diastolic \> 100 mm Hg which cannot be controlled by antihypertensive therapy;
• •6. Patients with intra-cardiac defibrillators or permanent pacemakers;
• •8. A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) including:
• •a. Presence of predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes)
• •9. Females who are nursing
• •10. A known diagnosis of Wilson's disease.
• •11. Patients with clinical symptoms consistent with active gastritis.
• •12. Patients with a condition that, in the opinion of the investigator, would interfere with the absorption of oral medication will be excluded from the study.
• •13. Patients requiring iron supplementation will be excluded.