E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulation |
Pacientes con carcinoma urotelial avanzado/metastásico con desregulación de los receptores ERBB |
|
E.1.1.1 | Medical condition in easily understood language |
urothelial cancer |
Cáncer urotelial |
|
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 | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
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 |
Assess efficacy of afatinib in urothelial cancer patients based on PFS |
Evaluar la eficacia de afatinib en pacientes con cáncer urotelial basada en la SLP |
|
E.2.2 | Secondary objectives of the trial |
objective response, best recist assessment, safety, survival |
Respuesta objetiva, la mejor valoración según criterios RECIST, seguridad, supervivencia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-recurrent or metastatic urothelial cancer
-patients must have failed prior platinum based treatment (adjuvant or 1st line)
-tumour sample for HER2/3 mutation testing and/or assessment of markers to determine basal histology must be available
Further criteria apply |
- cáncer urotelial metastásico o recurrente
- pacientes deben haber fracasado al tratamiento previo basado en platino (adyuvante o primera línea)
- muestra tumoral disponible para análisis de la mutación HER2/3 y/o evaluación de marcadores para determinar la histología basal.
Se aplican criterios adicionales |
|
E.4 | Principal exclusion criteria |
-Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
-Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
-Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
Further criteria apply |
- Tratamiento previo dirigido a EGFR, ERBB2 o ERBB3
- Quimioterapia en las 4 semanas previas al inicio del tratamiento del ensayo. Terapia biológica o agentes en investigación en las 4 semanas previas al inicio del tratamiento del ensayo o antes de que transcurran 5 semividas, es decir aclaramiento sistémico, lo que ocurra primero
- Metástasis cerebral conocida o signos de la misma, compresión incontrolada de la médula espinal o carcinomatosis leptomeníngea
Se aplican criterios adicionales |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Progression Free Survival at 6 months in Cohort A (defined as the proportion of patients who does not show disease progression by the 24-week tumour assessment). |
1: Supervivencia libre de progresión a los 6 meses para los pacientes de la Cohorte A (definida como la proporción de pacientes que no muestran progresión de la enfermedad en la evaluación tumoral a 24 semanas). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: 24 weeks |
1: 24 semanas |
|
E.5.2 | Secondary end point(s) |
1: Objective response rate (ORR), defined as number of complete response (CR) or partial response (PR) according to RECIST 1.1.
2: Progression free survival (PFS).
3: Overall Survival (OS)
4: Disease Control Rate (DCR)
5: Duration of objective response (DOR)
6: Tumour shrinkage |
1: Tasa de respuesta objetiva (TRO), definida como el número de respuesta completa (RC) o respuesta parcial (RP) según RECIST 1.1.
2: Supervivencia libre de progresión (SLP)
3: Supervivencia global (SG)
4: Tasa de control de la enfermedad (TCE)
5: Duración de la respuesta objetiva (DRO)
6: Disminución del volumen tumoral |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: From Baseline to End of Trial
2: From first drug administration to disease progression
3: From first drug adminitration to date of death
4: From first drug administration to disease progression
5: From first drug administration to disease progression
6: From first drug administration to disease progression |
1: Desde el periodo basal hasta la finalización del estudio
2: Desde la primera administración del medicamento hasta la progresión de la enfermedad
3: Desde la primera administración del medicamento hasta la fecha de la muerte
4: Desde la primera administración del medicamento hasta la progresión de la enfermedad
5: Desde la primera administración del medicamento hasta la progresión de la enfermedad
6: Desde la primera administración del medicamento hasta la progresión de la enfermedad |
|
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 | No |
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 | 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 | 19 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Yes |
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
|
LVLS |
El ensayo se considerará finalizado cuando el último paciente haya finalizado la última visita de seguimiento. |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 28 |