Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Melanoma

• Adult subjects with Stage III or IV non-resectable nonuveal (cutaneous or mucosal) metastatic melanoma who had received at least one but no more than two previous systemic therapies (immunotherapy and/or chemotherapy) for metastatic disease and who had not responded to or who had progressed after their most recent therapy were eligible for enrollment
• Presence of at least one lesion fulfilling the minimum Response Evaluation Criteria in Solid Tumors (RECIST) size requirements for a target lesion - Use of highly effective birth control methods in females of child-bearing potential
• Able to undergo either contrast enhanced computed tomography (CT) scan or contrast enhanced magnetic resonance imaging (MRI) scan for tumor assessment
• Life expectancy greater than 3 months
• Adequate organ and bone marrow functions as defined below: absolute neutrophil count ≥ 1500 /µL, platelets ≥ 100,000 /µL, creatinine ≤ 1.5 × upper limit of normal (ULN) or measured creatinine clearance of ≥ 60 mL/min x 1.73 m2 body surface area, total bilirubin ≤ 1.5 times ULN, aspartate aminotransferase or serum glutamic oxalacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase∗ ≤ 2.5 times ULN
• Negative serum pregnancy test within 2 weeks prior to receiving the first dose of study drug in female subjects of childbearing potential. Agreement to use a highly effective method of birth control throughout the study period and 3 months thereafter for sexually active males and females of childbearing potentia

Exclusion Criteria:

• Active malignancy in the last five years
• Pregnancy, breast feeding
• HIV infection
• Brain metastasis
• Concomitant use of corticosteroids or valproic acid
• Uncontrolled intercurrent illness
• Diagnosis of uveal melanoma
• Eastern Cooperative Oncology Group performance status ≥ 2
• Ongoing effects from previous investigational drug studies or concomitant participation in other investigational drug studies
• Prior use of MS-275 or any other HDAC inhibitor
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MS-275
• Anticancer therapy
• Active gastrointestinal conditions that might predispose for poor drug absorption
• Major surgery within 4 weeks prior to enrollment
• Hypophosphatemia \< 2.5 mg/dL at screening, if not corrected in the screening period
• Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study