A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With 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