E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A phase II clinical study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy |
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MedDRA Classification |
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 evaluate the objective tumour response in chemotherapy-naive patients with metastatic melanoma when treated with CP-4055 for infusion D1-5/4w. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the - Time to progression - Duration of tumour response - Safety and tolerability of the CP-4055 treatment
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy (chemotherapy-naive) 2. Measurable disease according to Response Criteria for Solid Tumors (RECIST) 3. Performance Status 0 – 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status 4. Age 18 years or more 5. Life expectancy > 3 months 6. Signed informed consent 7. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils above or equal to 1.5 x 109/L b. Platelets above or equal to 100 x 109/L c. Hb above or equal to 10 g/dL • Hepatic function: a. AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN b. Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN • Renal function: Creatinine ≤ 1.5 times institutional ULN
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E.4 | Principal exclusion criteria |
1. Known brain metastases 2. Diagnosis of ocular malignant melanoma 3. Radiotherapy to more than 30 % of bone marrow 4. Participation in another therapeutic Clinical Study within 30 days of enrolment or during this Clinical Study 5. Prior immuno- and/or chemotherapy including vaccines for the treatment of melanoma 6. Requirement of concomitant treatment with a non-permitted medication: • Alternative drugs • High doses of vitamins 7. History of allergic reactions to Ara-C or egg 8. Presence of any serious concomitant systemic disorders incompatible with the Clinical Study (e.g. uncontrolled inter-current illness including ongoing or active infection) 9. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 10. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients 11. Known positive status for HIV and/or hepatitis B or C 12. Any reason why, in the Investigator’s opinion, the patient should not participate 13. Drug and/or alcohol abuse
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E.5 End points |
E.5.1 | Primary end point(s) |
Tumour response defined as Complete Response (CR) and/or Partial Response (PR), characterized by measuring the target lesions, and according to the RECIST criteria. The Response Rate (= PR + CR) will be estimated and a 95 % confidence interval calculated.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |