Metastatic malignant melanoma MedDRA version: 8.1 Level: LLT Classification code 10027480 Term: Metastatic malignant melanoma
Conditions
Interventions
Trade Name: Pharmorubicin
Pharmaceutical Form: Solution for infusion
Trade Name: Clinoril
Pharmaceutical Form: Tablet
Sponsors
ICORG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients must have a histologically documented malignant melanoma which is metastatic, and their tumour block should be available for resistance marker analysis. •Patients must have either measurable or evaluable disease. •Patients must have a Karnofsky Performance Status >70%. •Patients must have a normal cardiac ejection fraction and normal cardiac wall motion and ECG. •Patients must have the following haematological parameters: absolute neutrophil count: > 1.0 x 109/L, platelet count > 100 x 109/L, haemoglobin >9 g/dl. •Patients must have normal serum bilirubin except patients with benign congenital hyperbilirubinaemia. •Patients must have signed informed consent (Appendix II) indicating full understanding of the risks and potential benefits of the research as outlined in the information sheet. •Patients must be older than 18 years of age. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients must not have active heart disease, including a history of myocardial infarction within one year, pericarditis or existing hypertension requiring treatment. •Patients must not have had a prior anthracycline or anthracenedione-containing chemotherapy regime or cardiac radiotherapy. •Patients with active brain metastases are ineligible. Patients who have had successful complete excision of solitary brain metastasis are not excluded. •Patients must not be pregnant or lactating. Pre-menopausal women must have a negative pregnancy test. •Patients must not have had major surgery within the previous 2 weeks. •Patients must not have participated in any clinical trial within the previous four weeks. •Patients must not be treated with any other anti-cancer therapies during the study period, with the exception of patients who are on bisphosphonate therapy for bony metastases. Such patients must have extra-osseous measurable/evaluable lesions •Patients must not receive any other experimental medications during the study period. •Patients must not have any other active serious medical or psychiatric disease. •Patients must not have had a prior or concomitant malignancy, other than basal cell carcinoma of the skin or in-situ neoplasia of the cervix uteri.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the non-comparative efficacy of this treatment combinations in patients with malignant melanoma;Secondary Objective: To characterise the toxicity of this combination in this patient population;Primary end point(s): Response (complete response, partial response or stable disease) | — |
Countries
Ireland
Outcome results
None listed