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

Thallion Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Drug: TLN-232

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735332

TLN-232-202

Details and patient eligibility

About

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.

Enrollment: 49 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Single-Arm

Experimental group

Treatment:

Drug: TLN-232