E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028980 |
E.1.2 | Term | Neoplasm |
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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 |
The main objective of this disease-oriented phase II, open-label, non-controlled study is to evaluate the objective response of 177Lu-DOTATATE treatment in patients affected by sst2 positive tumours. |
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E.2.2 | Secondary objectives of the trial |
The second objective is to evaluate the acute toxicity to and the time to progression in the single tumour histotypes. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients, male and female, with the following: - Histologic diagnosis of neuroendocrine tumors or any other tumor histotype, documented as sst2-positive (breast, small cell lung cancer, Hodgkin and Non-Hodgkin lymphoma, high-grade glioma), that may benefit from receptor radionuclide therapy and for which there arent any other effective treatments. - Conserved hematological, liver and renal parameters, and in particular: - WBC >2500/μl (ANC>1500/μl); Hb>10g/dl; PTL >100.000/μl; Bilirubin <2.5 mg/dl; Creatinin <2 mg/dl; - Age > 18 years; - Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan images demonstrate a significant uptake in the tumour. The tumour uptake will be evaluated with a 3-grade scale, where 1 is the liver uptake and 3 the kidney one: only tumour uptakes grade 2 and 3 will be considered for therapy. - Both local relapses and metastases will be treated. - Disease must be measurable by means of conventional imaging (US, CT, RM). - Before treatment anamnestic data will be collected, physical examination will be performed and diagnostic and laboratory data will be examined. - Patients must not receive other treatments (e.g. chemo- or radiotherapy) from one month before to two months after the completion of 177Lu-DOTATATE cycles. - Before the radiopharmaceutical administration, each patient will be informed about the nature, aim and potential risks of the study, and will sign an informed consent (see attached document n.1) before the beginning of therapy. Principal investigator must guarantee that the research will be conducted according to the Declaration of Helsinki, in 1964, revised during the 41st World Medical Assembly, in 1989 in Hong Kong, the 48th (Somerset West, 1996) and the 52nd (Edinburgh, 2000) World Medical Assemblies. |
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E.4 | Principal exclusion criteria |
- Patients not corresponding to the above criteria. - Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory). - Assessed bone marrow invasion. - Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers). - ECOG score higher than 2. - Expectancy of life shorter than 6 months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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 | 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) | 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 | 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
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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |