E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
non small cell lung cancer |
Cáncer de pulmón de células no pequeñas |
|
E.1.1.1 | Medical condition in easily understood language |
lung cancer |
Cáncer de pulmón |
|
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 | 10061873 |
E.1.2 | Term | Non-small cell lung 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 |
To allow continued treatment to patients receiving ceritinib in existing Novartis sponsored studies which have fulfilled the requirements for the primary objective, and in the opinion of the investigator, would benefit from continued treatment. |
Permitir que los pacientes que reciben ceritinib, en estudios patrocinados por Novartis que cumplan los requisitos del objetivo principal y que, según el criterio del investigador, vayan a beneficiarse del tratamiento continuado puedan continuar el tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
To collect safety data: adverse events (AEs) and serious adverse events (SAEs). |
Recoger datos de seguridad: acontecimientos adversos (AA) y acontecimientos adversos graves (AAG). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment. ? Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. ? Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures. ? Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Other protocol defined inclusion criteria may apply. |
- Pacientes que estén recibiendo actualmente tratamiento con ceritinib en un estudio patrocinado por Novartis que cumpla los requisitos del objetivo principal y, que según el criterio del investigador, se podrían beneficiar del tratamiento continuado. - Pacientes que hayan demostrado cumplir los requisitos del protocolo del estudio principal según lo evaluado por el investigador. - Voluntad y capacidad para cumplir con las visitas programadas, los planes detratamiento y cualquier otro procedimiento del estudio. - Pacientes que hayan proporcionado el consentimiento informado por escrito antes de entrar en el estudio de extensión y de recibir la medicación del estudio. Si el consentimiento no puede expresarse por escrito, deberá ser documentado formalmente y con testigo, preferiblemente con un testigo de confianza independiente.
Pueden aplicar otros criterios de inclusión definidos en el protocolo |
|
E.4 | Principal exclusion criteria |
? Patient has been permanently discontinued from ceritinib study treatment in the parent study due to any reason. ? Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ceritinib dosing to resume.) ? Patient?s indication is currently approved and reimbursed in the local country. ? Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. ? Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception. ? Sexually active males unless they use a condom during intercourse while taking drug and after stopping ceritinib and should not father a child in this period.
Other protocol defined exclusion criteria may apply. |
- Pacientes que hayan suspendido permanentemente el tratamiento con ceritinib en el estudio principal por cualquier motivo. - Pacientes que actualmente presenten toxicidades no resueltas por las que se haya interrumpido la administración de la dosis de ceritinib en el estudio principal. (Los pacientes que cumplan todos los demás criterios de elegibilidad pueden entrar en el estudio una vez resueltas estas toxicidades para que se pueda reanudar la administración de la dosis de ceritinib). - Pacientes cuya indicación se haya aprobada y reembolsada actualmente en su país. - Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la analítica de hCG en suero. - Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando métodos anticonceptivos altamente eficaces. - Varones sexualmente activos, salvo que utilicen un preservativo durante el coito mientras estén tomando el fármaco y después de la suspensión del tratamiento con ceritinib, y no deberán engendrar hijos durante al menos los 3 meses posteriores a la última dosis de tratamiento.
Pueden aplicar otros criterios de exclusión definidos en el protocolo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of patient recieving ceritinib |
Número de pacientes que reciben ceritinib |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
No stastitical analysis will be performed. |
No se realizará ningún análisis estadístico |
|
E.5.2 | Secondary end point(s) |
Frequency and nature of adverse events and serious adverse events |
Frecuencia y naturaleza de los acontecimientos adversos y los acontecimientos adversos graves |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The assessment of safety will be based on the frequency of adverse events (AEs) and serious adverse events (SAEs) |
La evaluación de seguridad se basará en la frecuencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG). |
|
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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To allow continued treatment to patients receiving ceritinib in existing global Novartis sponsored studies who are benefiting from treatment after conclusion of the parent study. |
Permitir que los pacientes que reciben ceritinib, en estudios patrocinados por Novartis que cumplan los requisitos del objetivo principal y que, según el criterio del investigador, vayan a beneficiarse del tratamiento continuado puedan continuar el tratamiento. |
|
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.8.3 |
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 | 28 |
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 |
France |
Germany |
Hong Kong |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Norway |
Russian Federation |
Singapore |
Spain |
Sweden |
Taiwan |
Thailand |
United Kingdom |
United States |
|
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 end of the study will occur after all patients in the study have completed their last assessment per protocol. The last assessment for each patient is the follow-up visit that occurs 30 days after the patient?s last dose of study treatment or until SAE follow up is resolved as required, whichever is later. |
El fin de estudio se producirá después de que todos los pacientes del estudio hayan completado su última evaluación conforme al protocolo. La última evaluación para cada paciente es la visita de seguimiento que se produce 30 días después de la última dosis del tratamiento del estudio del paciente o hasta que se resuelva el seguimiento de un AAG según sea necesario, lo que ocurra más tarde. |
|
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 | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 3 |