E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | This is a non-randomized, non-controlled, open label, multicenter phase II study to evaluate the efficacy and safety of PTK 787/ ZK 222584 in the treatment of patients with·progressive neuroendocrine tumors who will not qualify for curative resection of the tumor. | |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | Improvement/ extension of Time to progression | |
E.2.2 | Secondary objectives of the trial | - Improvement of Response rate according to RECIST criteria or tumor stabilization in patients with progressive disease demonstrated within the last six months prior to start of PTK787/ZK 222584 therapy - Improvement/ extension of Survival time - Decrease of tumor markers ( Chromogranin A, 5-HIES) - Increase or stabilization of Body weight· - Improvement of Subjective general condition (WHO performance status) - Improvement of Quality of life (EORTC QLQ C30) - Toxicity and safety | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | - Histologically and immunohistologically confirmed neuroendocrine carcinoma - Neuroendocrine tumor of foregut, midgut, hindgut or CUP with demonstrated progress within the last 6 months - KI 67 < 15% - Presence of measurable tumor lesions as determined by RECIST criteria | |
E.4 | Principal exclusion criteria | - High grade malignant neuroendocrine tumor (Ki 67 >15%) - Chemotherapy 4 weeks prior to entry on this study - Embolisation or chemoembolisation less than 3 month prior to entry on this study - Major surgery within 2 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy - Patients who have received investigational drugs within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy - Patients who are pregnant or breast feeding - Adults of reproductive potential not employing an effective method of birth control (such as barrier methods). Oral, implantable or injectable contraceptives are not considered effective for this study due to potential CYP450 interaction - Current severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease or active uncontrolled infection) which could compromise participation in the study - Acute or chronic active liver disease (e.g., hepatitis, cirrhosis) - Presence of clinically symptomatic brain metastasis - Confirmed HIV infection - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea which leads to malabsorption, malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets) - Second malignant tumor (except non-melanoma skin tumors and carcinoma in situ of the cervix) - Patients who are taking Coumadin (warfarin sodium) or other medication metabolized by cytochrome p450, heparin is acceptable | |
E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Information not present in EudraCT |
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 | 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 | 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 | 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 | The study period is one year. A reduced treatment period is indicated if the patient experiences unacceptable toxicity, in case of disease progression or if treatment with PTK787/ZK 222584 is delayed for more than 3 weeks. With demonstrated tumor stabilization during the complete study period treatment can be continued after approval by the the Principle Investigator. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |