E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with malignant neuroendocrine tumours, not amenable to surgical treatment or radiofrequency ablation. Renal, bone marrow and liver function must be sufficient. |
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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 |
Clarify the effect of the treatment with 177-Lu-DOTA-octreotate, regarding a) tumour size b) biochemical response, c) prognostic factors such as proliferation markers and LD/ALP and type of tumour, d) quality of life, e) survival and f) progression free survival. |
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E.2.2 | Secondary objectives of the trial |
Optimize the treatment based on a dosimetry protocol developed in Uppsala. Is it possible to safely administer more than the four treatments from the Rotterdam protocol based on this dosmetry model, and can the therapeutic effect be further improved over time? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients either with carcinoids originating from lung, thymus, stomach, duodenum, small bowel, large bowel, rectum, or • Patients with endocrine pancreatic tumours, or • Patients with malignant pheochromocytoma/paraganglioma • Uptake at least grade 3 according to Krenning sckale (0–4) at OctreoScan, (i.e. somatostatin receptor expression higher than normal liver), not older than 6 months • Life exspektancy more than 3 months • WBC >3,0x109/L • Neutrophils >1,5x109/L • Platelet count >100x109/L • Bilirubin <40 μmol/L • Albumin >25 g/L • ASAT/ALAT ≤5 times upper reference limit • Creatinine <110 μmol/L • GFR ≥50 ml/min/1,73 |
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E.4 | Principal exclusion criteria |
• Tumors accessible to surgery or radiofrequency ablation • Decreased renal function: Creatinine >110 μmol/L and/or GFR <50 ml/min/1,73 • Platelet count <100x109/L • WBC <3,0x109/L • Neutrophils <1,5x109/L • Moderately/severely impaired liver function • Very large tumour load in the liver with high uptake on OctreoScan • Pregnancy • Inability to manage the personal hygiene • Inablity to be isolated for 24 hours • Proliferation >20–30% (Ki67-positive tumour cells) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Radiological response rate according to RECIST criteria |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | Yes |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |