Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma

Inclusion Criteria: * Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous) * First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them) * Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1 * Age ≥ 18 years * ECOG ≤ 2 * Normal organ and marrow function as defined below: * Leukocytes ≥2.5 x 109/L * Absolute neutrophil count ≥1.5 x 109/L * Platelets ≥100 x 109/L * Hemoglobin ≥100 g/L (10g/dL) * Total bilirubin ≤1.5 X institutional ULN * AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN * Creatinine ≤1.5 X institutional ULN Exclusion Criteria: * Patients with a life expectancy ≤ 16 weeks * Patients with ocular melanoma * Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1 * Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues * Patients with a documented history of HIV, active hepatitis B or C infection * Female patients who are pregnant or lactating * Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted) * Patients with grade ≥2 peripheral neuropathy (CTCAE criteria) * Patients in whom a proper central line cannot be established