E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Haematologic and non-haematologig malignancies in patients who have participated in clinical studies with CEP-701 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10059034 |
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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 |
Safety and tolerability of long term use of CEP-701 in patients affected by advanced malignancies |
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E.2.2 | Secondary objectives of the trial |
Objective time to disease progression |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The patient participated in a previous clinical study of oral CEP-701 and would benefit by continuing treatment with CEP-701. Patients randomized to chemotherapy alone in study C0701a/204/ON/US may also be included in this study if in the opinion of their physician they might benefit by receiving oral CEP-701 aged 18 years and older written informed consent is obtained The patient has a diagnosis of haematologic or non-haematologic malignancy The patient must be willing and able to comply with study restrictions and to return to the clinic for clinical and follow-up evaluations as specified in this protocol. The patient must enter the study within 30 days of participating in the previous clinical study of CEP-701; or if the patient received chemotherapy after the previous study of CEP-701, within a window of 3 to 14 days after receiving the last dose of chemotherapy women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test result at study entry. |
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E.4 | Principal exclusion criteria |
active gastrointestinal ulceration or bleeding bilirubin levels greater than 2 times upper limit of normal ULN , alanine transaminase or aspartate transaminase levels greater than 3 times ULN serum creatinine concentrations greater than 2.0 mg/dL The patient has a non-haematological malignancy and one or more of the following abnormal haematologic values - haemoglobin below 9 g/dL - patelets count below 100000/ 956;L - absolute neutrophil counts below 1500 / 956;L The patient requires current treatment for the human immunodeficiency virus with protease inhibitors or requires potent CYP3A4 inhibitors cyclosporine, clotrimazole, fluconazole, itraconazole, voriconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin, and nefazodone |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability of long term use of CEP-701 in patients affected by advanced malignancies |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | No |
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 | Information not present in EudraCT |
E.8.2.3.1 | Comparator description |
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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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 30 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |