Overview

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

Status:
Terminated
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Thallion Pharmaceuticals
Criteria
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