E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic malignant melanoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027480 |
E.1.2 | Term | Metastatic malignant melanoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To estimate the non-comparative efficacy of this treatment combinations in patients with malignant melanoma |
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E.2.2 | Secondary objectives of the trial |
To characterise the toxicity of this combination in this patient population |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Response (complete response, partial response or stable disease) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |