E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cancer patients |
pazienti oncologici |
|
E.1.1.1 | Medical condition in easily understood language |
cancer patients |
pazienti con tumore |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10014713 |
E.1.2 | Term | Endocrine neoplasms malignant and unspecified |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
disease control rate, DCR, defined as the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start |
controllo della malattia (risposte complete, parziali e stabilità da almeno 12 mesi) |
|
E.2.2 | Secondary objectives of the trial |
Late and acute toxicity - PFS (progression free survival) - OS (overall survival) - to combine with appropriate statistical methods, the data of the present study and the previous one already concluded (data in press) - to evaluate clinical endpoints (DCR, PFS, OS) in two subgroups of patients according to the disease status at study entry: PD (progression of disease within 12 months before study entry) and other status of disease - to investigate the predictive value of FDG-PET/CT on PFS. |
- tossicità acuta e tardiva - PFS - OS - clinical endpoints in 2 gruppi di pazienti divisi sulla base dello stato della malattia al momento dell'inclusione (PD vs non PD) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must have histologically or cytologically confirmation 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 etc…….), that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. Any disease stage is allowed. Patient could be enrolled with progressive disease (PD within the last 12 months from treatment start) but also with non progressive disease. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour. |
- età > 18 anni - i pazienti devono avere diagnosi istologica o citologica di tumore neuroendocrino o di qualsiasi altro istotipo purchè positivo agli sst2 (mammella, SCLC, Linfoma Hodgkin e non Hodking, glioma ad alto grado etc..) che possano trarre beneficio da una terapia radiometabolica recettoriale e per cui non ci siano altri trattamenti efficaci; - malattia misurabile in accordo con i criteri RECIST per i tumori solidi o i criteri di risposta rivisti per i linfomi maligni (Cheson BD, JCO 2007,25:579-586); - i pazienti possono trovarsi in qualsiasi stato di malattia; - i pazienti con malattia documentata verranno inclusi solo se le l’Octreoscan e/o le immagini della PET/TC con 68Ga-peptide, dimostrano un significativo uptake del tumore; - pazienti con o senza progressione di malattia nel periodo precedente allo studio, refrattari ai trattamenti convenzionali standard; - ECOG performance status ≤ 2; |
|
E.4 | Principal exclusion criteria |
- pazienti già trattati con 177Lu-dotatate o 90Y-dotatoc, a dosi cumulative superiori a 600 mCi e 200 mCi rispettivamente - pazienti trattati con CT e RT da meno di 4 settimane - pazienti con gravi comorbidità |
1. Patients treated with previous peptide receptor radionuclide therapy with 177Lu-dotatate or 90Y-dotatoc, with cumulative activities above 600 mCi e 200 mCi respectively 2. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy). 3. All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v.3.0) <= 1. 4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 5. Assessed bone marrow invasion > 50% 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main objective of this phase II study is to consolidate the role of 177Lu-DOTATATE in the management of neuroendocrine tumors and other sst2 positive tumours in terms of disease control rate, DCR, defined as the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population with no risk factors and on patient population with at least one risk factor. |
controllo della malattia (risposte complete, parziali e stabilità da almeno 12 mesi) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Late and acute toxicity - PFS (progression free survival) - OS (overall survival) - to combine with appropriate statistical methods, the data of the present study and the previous one already concluded (data in press) - to evaluate clinical endpoints (DCR, PFS, OS) in two subgroups of patients according to the disease status at study entry: PD (progression of disease within 12 months before study entry) and other status of disease - to investigate the predictive value of FDG-PET/CT on PFS. |
- tossicità acuta e tardiva - PFS - OS - clinical endpoints in 2 gruppi di pazienti divisi sulla base dello stato della malattia al momento dell'inclusione (PD vs non PD) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Information not present in EudraCT |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | No |
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
|
progression visit of the last patient in FUP |
visita di progressione dell'ultimo paziente |
|
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 | 0 |