| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy | |
| 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 | | To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study´s inclusion, the efficacy of Somatuline Autogel in tumour´s growth stabilization. | |
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | 1. The patient must give written informed consent prior to any study-related procedure. Informed consent must be given in writing except for patients who were unable to do it, in this case witnessed oral informed consent will be accepted.
2. Patients from both genders and over 18 years of age.
3. Patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification.
4. Patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours), present measurable disease (1).
(1) measurable disease: existence of at least one lesion which can be accurately
measured in at least one dimension and with longest diameter ≥20 mm using
conventional techniques or ≥10 mm with CT spiral scan.
5. Patients with progressive disease in the previous 6 months before their inclusion in the study. Is is needed to demonstrate the appearance of one or more new lesions or an increase ≥20% of the sum of the longest diameters of "target lesions" (2) or an unequivocal progression of "not target lesions" (3).
(2) "target lesions": all measurable lesions up to a maximum of 5 per organ and
10 lesions in total. Size (lesions with the longest diameter) and their
suitability for accurate repeated measurements will be taken into account for
their selection.
(3) "not target lesions": all lesions, or disease locations (e.g. ascites, pleural
effusion), not regarded as "target lesions".
6. Patients with 0-2 punctuation in the ECOG Scale (Eastern Cooperative Oncological Group) for general condition assessment.
0 Fully active, able to carry on all pre-disease performance without restriction.
1 Restricted in physically strenuous activity but ambulatory and able to carry
out work of light or sedentary nature, e.g., light house work, office work.
2 Ambulatory and capable of all selfcare but unable to carry out any work
activities. Up and about more than 50% of awaking hours.
3 Capable of only limited selfcare, confined to bed or chair more than 50% of
awaking hours.
4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or
chair.
7. Patients with positive (111-In-DTPA-D-Phe) octreotide scintigraphy.
| |
| E.4 | Principal exclusion criteria | 1. Patients with surgical removable localised disease.
2. Patients with progressive disease in the first six months of being diagnosed.
3. Patients with carcinoid tumours which cause intestinal obstruction.
4. Patients with life expectancy under 12 weeks.
5. Patients who have received treatment with somatostatine analogues during the 6 months before being included in the study.
6. Patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned during the study.
7. Patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.
8. Breast-feeding or pregnant women (Beta-HCG will be measured before the patients are included) or high risk of getting pregnant due to inadequate contraceptive measures.
9. Patients with physical comorbidity or mental or social alteration that prevent them to understand and carry out the treatment. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | Time until disease progression, that is, according to RECIST criteria (Response Evaluation Criteria in Solid Tumors), appearance of one or more new lesions or an increase ≥20% of the sum of the longest diameters of "target lesions" taking as reference the baseline sum of longest diameters recorded at the beginning of the study, or an unequivocal progression of "not target lesions". | |
| 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) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| 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) | 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.8.5 | 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 | 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 | | Last visit of the last patient recruited in the trial | |
| 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 | 3 |
| E.8.9.1 | In the Member State concerned days | |
