Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Philadelphia, Pennsylvania


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.


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



Primary Contact:

Principal Investigator
David Hogg, MD
Princess Margaret Hospital, Toronto

Backup Contact:


Location Contact:

Philadelphia, Pennsylvania
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.