E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A multicentre, dose finding, phase II Study of CP-4055 in combination with Sorafenib in patients with metastatic malignant melanoma
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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 patients with metastatic malignt melanoma when treated with CP-4055 for infusion D1-5/4w in combination with sorafenib |
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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 treatment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have or have not undergone prior bio- and/or chemotherapy for treatment of melanoma 2. Measurable disease according to Response Criteria for Solid Tumors (RECIST) 3. Performance Status 0 – 1 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. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. 8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose 9. 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 less than or equal to 2.5 times institutional upper limit of normal (ULN). If liver metastases, less than or equal to 5 times institutional ULN b. Serum bilirubin and alkaline phosphatase less than or equal to 1.5 times institutional ULN • Renal function: Creatinine less than or equal to 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. Requirement of concomitant treatment with a non-permitted medication: • Alternative drugs • High doses of vitamins • Antikoagulant medication, i.e. Marevan, Coumarin, Jantovan, and Waran (warfarin) 6. History of allergic reactions to Ara-C or egg 7. History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib 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. Drug and/or alcohol abuse 13. Any reason why, in the Investigator’s opinion, the patient should not participate 14. Prior treatment with CP-4055 and/or sorafenib 15. Significant history of cardiac disease, including any of the following: •Uncontrolled hypertension •Unstable angina pectoris •Congestive heart failure •Myocardial infarction within the past 6 months •Unstable ventricular arrhythmia •Other cardiac arrhythmia 16. Condition that impairs ability to swallow pills 17. Tendency of bleeding
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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 | 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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |