Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Thallion Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
