Melanoma
Conditions
Keywords
Melanoma, Metastatic Melanoma, Phase II, Skin Cancer
Brief 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.
Interventions
DRUGTLN-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
Sponsors
Thallion Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1). | Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1) |
Secondary
| Measure | Time frame |
|---|---|
| To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma | Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1) |
Countries
Canada, United States
Outcome results
None listed