PHASE II TRIAL OF THE MULTI-DRUG RESISTANCE PROTEIN MODULATING AGENT SULINDAC IN COMBINATION WITH EPIRUBICIN IN PATIENTS WITH ADVANCED MELANOMA - Phase II Melanoma trial

• Conditions: Metastatic malignant melanoma; MedDRA version: 8.1Level: LLTClassification code 10027480Term: Metastatic malignant melanoma

• Registration Number: EUCTR2006-006051-12-IE
• Lead Sponsor: ICORG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)