E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Various Types of cancer (dependent on parent study) |
Vari tipi di cancro (dipendente dallo studio genitore) |
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E.1.1.1 | Medical condition in easily understood language |
Various Types of cancer (dependent on parent study) |
Vari tipi di cancro (dipendente dallo studio genitore) |
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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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049280 |
E.1.2 | Term | Solid tumour |
E.1.2 | System Organ Class | 100000004864 |
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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 |
To monitor long-term safety of durvalumab |
Monitorare la sicurezza a lungo termine di durvalumab (tutte le coorti) |
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E.2.2 | Secondary objectives of the trial |
-To assess the efficacy of durvalumab in terms of overall response rate (ORR) and duration of response (DOR) in patients who undergo retreatment with durvalumab -To assess the overall survival (OS) of patients |
• Valutare l’efficacia di durvalumab in termini di tasso di risposta complessiva (ORR) e durata della risposta (DR) in pazienti sottoposti a un ritrattamento con durvalumab (solo Coorte 2) • Valutare la sopravvivenza complessiva (OS) dei pazienti (tutte le coorti) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patient must be 18 years or older, at the time of signing the ICF. For subjects aged <20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative. 2.Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study. 3.Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen). 4.Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures. |
1. Il paziente deve avere almeno 18 anni al momento della firma dell'ICF. Per soggetti di età inferiore ai 20 anni e arruolati in Giappone, è necessario ottenere un ICF scritto dal soggetto o dal suo rappresentante legalmente accettabile. 2. Il paziente ha ricevuto una combinazione di durvalumab in monoterapia e / o durvalumab in uno studio clinico parent sponsorizzato da AstraZeneca / MedImmune che è stato approvato per l'iscrizione a questo studio. 3. I pazienti che hanno ricevuto durvalumab in associazione con altri agenti antitumorali approvati o sperimentali nello studio clinico genitore devono aver completato o sospeso tutte le altre terapie antitumorali (oltre il regime di durvalumab). 4. Il paziente deve essere disposto e in grado di fornire un consenso informato scritto e di rispettare le visite programmate e altre procedure di studio. |
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E.4 | Principal exclusion criteria |
The following exclusion criteria apply only to patients receiving treatment or retreatment: 1.Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab 2.Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment 3.Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study 4.Diagnosis of a new primary malignancy since enrollment into the parent clinical study |
I seguenti criteri di esclusione si applicano solo ai pazienti che ricevono un trattamento o un ritrattamento: 1. Attualmente in trattamento in un altro studio interventistico diverso dallo studio clinico parent o, per i pazienti in ritrattamento, ha ricevuto un trattamento durante il periodo di follow-up con un agente diverso da durvalumab 2. Qualsiasi chemioterapia concomitante, PI, terapia biologica o ormonale per il trattamento del cancro 3. Esperienza di tossicità immuno mediata o non immuno mediata che ha portato alla sospensione permanente di durvalumab nello studio clinico parent 4. Diagnosi di un nuovo tumore maligno primario dall'arruolamento nello studio clinico genitore |
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E.5 End points |
E.5.1 | Primary end point(s) |
-All serious adverse events (SAEs) -Non-serious adverse events (AEs) that lead to dose modification, drug discontinuation, or withdrawal from the study -All Grade 3 and Grade 4 adverse events (AEs) -Grade 2 adverse events (AEs) that affect vital organs (eg, heart, liver) -Immune-mediated adverse events (AEs) -Laboratory findings qualifying as an serious adverse events/adverse events (SAE/AE) |
-Tutti gli eventi avversi gravi (SAE) -Eventi avversi non gravi (eventi avversi) che portano alla modifica della dose, farmaco interruzione o ritiro dallo studio -Tutti gli eventi avversi di grado 3 e grado 4 (eventi avversi) -Grado 2 eventi avversi (eventi avversi) che colpiscono gli organi vitali (ad es. Cuore, fegato) Eventi avversi immuno-mediati (eventi avversi) - Risultati del laboratorio che si qualificano come eventi avversi / eventi avversi gravi (SAE / AE) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Various time points trough the study |
Vari punti temporali attraverso lo studio |
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E.5.2 | Secondary end point(s) |
-Overall response rate (ORR): percentage of patients with a confirmed response of CR or PR. -Duration of response (DOR): Time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. -Overall survival (OS):Time from date of randomization/enrollment in the parent clinical study until the date of death by any cause. |
-Tasso di risposta globale (ORR): percentuale di pazienti con una risposta confermata di CR o PR. -Durata della risposta (DOR): tempo dalla prima CR o PR documentata al momento della prima progressione della malattia documentata o morte in assenza di progressione della malattia. - Sopravvivenza globale (OS): tempo dalla data di randomizzazione / iscrizione nello studio clinico genitore fino alla data di morte per qualsiasi causa. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Various time points trough the study |
Vari punti temporali attraverso lo studio |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 150 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
Canada |
Israel |
Japan |
Korea, Republic of |
Russian Federation |
Serbia |
Taiwan |
Thailand |
Ukraine |
United States |
Vietnam |
Belgium |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Romania |
Spain |
Switzerland |
United Kingdom |
Czechia |
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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
|
The study is anticipated to close when the last patient has discontinued treatment. |
Si prevede che lo studio si chiuderà quando l'ultimo paziente ha interrotto trattamento. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |