E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Various types of cancer ( dependent on parent study) |
Varios tipos de cáncer (depende del ensayo previo) |
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E.1.1.1 | Medical condition in easily understood language |
Various types of cancer ( dependent on parent study) |
Varios tipos de cáncer (depende del ensayo previo) |
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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 |
Supervisar la seguridad a largo plazo de durvalumab |
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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 |
-Evaluar la eficacia de durvalumab en términos de tasa de respuesta global (TRG) y duración de la respuesta (DR) en los pacientes que se sometan a la repetición del tratamiento con durvalumab -Evaluar la supervivencia general (SG) de los pacientes |
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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. Los pacientes deben tener 18 años de edad o más en el momento de firmar el FCI. Para los sujetos menores de 20 años de edad e inscritos en Japón, se debe obtener un FCI por escrito del sujeto y su representante legal. 2. Los pacientes deben haber recibido durvalumab en monoterapia y/o una combinación que incluyese durvalumab en un estudio clínico principal promovido por AstraZeneca/MedImmune con autorización para su inscripción en este estudio. 3. Los pacientes que hayan recibido durvalumab en combinación con otro tratamiento antineoplásico autorizado en un estudio principal deben haber finalizado o interrumpido el resto de tratamientos antineoplásicos (además de la pauta de durvalumab). 4. Los pacientes deben estar dispuestos y ser capaces de otorgar el consentimiento informado por escrito y cumplir con las visitas programadas y otros procedimientos del estudio. |
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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 |
Los siguientes criterios de exclusión aplican unicamente a pacientes que reciben tratamiento o retratamiento: 1. Pacientes que se encuentren actualmente en tratamiento en otro estudio clínico o para pacientes con retratamiento, o que han recibido tratamiento durante el periodo de seguimiento con un agente que no sea durvalumab 2. Cualquier tratamiento concomitante de quimioterapia, producto en investigación (PEI), biológico u hormonal para el tratamiento del cáncer 3. Pacientes que hayan sufrido una toxicidad inmunitaria o no inmunitaria que haya dado lugar a la interrupción con durvalumab en el estudio clínico principal. 4. Diagnóstico de nueva neoplasia primaria desde la inscripción en el estudio clínico principal |
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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) |
-Todos los acontecimientos adversos graves (AAG) -Los acontecimientos adversos (AA) no graves que conlleven la modificación de la dosis, interrupción del tratamiento con el fármaco o la retirada del ensayo -Todos los acontecimientos adversos (AA) de grado 3 y grado 4 -Acontecimientos adversos (AA)de grado 2 que afecten a los órganos vitales (por ejemplo, corazón o hígado) -Acontecimientos adversos (AA) inmunitarios -Resultados analíticos que cumplan los requisitos para considerarlos acontecimientos adversos graves/acontecimientos adversos (AAG/AA) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Various time points trough the study |
Varios puntos de tiempo del ensayo |
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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. |
-Tasa de respuesta global TRG: porcentaje de pacientes con respuesta completa (RC) o respuesta parcial (RP) confirmada -Duración de la respuesta (DR): tiempo desde la primera documentación de RC o RP hasta el momento de la primera documentación de progresión de la enfermedad o muerte en ausencia de progresión de la enfermedad -Supervivencia general (SG): tiempo transcurrido desde la fecha de la aleatorización/inscripción en el estudio clínico principal hasta la fecha de la muerte por cualquier causa |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Various time points trough the study |
Varios puntos de tiempo del ensayo |
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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 | No |
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 | No |
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 | 17 |
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 | No |
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 |
Belgium |
Brazil |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Poland |
Romania |
Russian Federation |
Serbia |
Spain |
Switzerland |
Taiwan |
Thailand |
Ukraine |
United Kingdom |
United States |
Vietnam |
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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. |
Se anticipa que el estudio concluya cuando el último paciente haya interrumpido el tratamiento. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |