Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT00735332
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00735332
Study Brief:
Protocol Section:
NCT00735332