E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study and are benefiting from the treatment as judged by the investigator. All objectives of the parent study must have been reached, and the parent study must be in the process of being completed and reported. |
Pacientes que actualmente participen en un estudio de desarrollo clínico y asuntos médicos de Oncología, patrocinado por Novartis, que reciban nilotinib y hayan cumplido todos sus requisitos en el estudio matriz |
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E.1.1.1 | Medical condition in easily understood language |
Patients who are enrolled in a Novartis speonsored Oncology study which has met its study objectives and who are benefiting from tretament with nilotinib. |
Pacientes que participan y se benefician del tratamiento con nilotinib en un estudio de Novartis Oncología que ha cumplido sus objetivos. |
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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 | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062427 |
E.1.2 | Term | Gastrointestinal stromal tumor |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009700 |
E.1.2 | Term | CML |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To allow continued use of nilotinib to patients receiving nilotinib in a Novartis-sponsored Oncology CD&MA study which has reached its objectives and who are benefiting from treatment with nilotinib. |
Permitir el uso continuado de nilotinib a pacientes que reciban nilotinib en un estudio de CDyMA de Oncología, patrocinado por Novartis que haya alcanzado sus objetivos y que se estén beneficiando del tratamiento con nilotinib. |
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E.2.2 | Secondary objectives of the trial |
To collect long term data on serious adverse events. |
Recoger datos a largo plazo de acontecimientos adversos graves. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study. 2. Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study. Other inclusion criteria as defined in the protocol apply. |
1.Pacientes que actualmente participen en un estudio de desarrollo clínico y asuntos médicos de Oncología, patrocinado por Novartis, que reciban nilotinib y hayan cumplido todos sus requisitos en el estudio matriz. 2.Pacientes que actualmente se estén beneficiando del tratamiento con nilotinib, determinado por el investigador. 3.Pacientes que hayan demostrado cumplimiento, evaluado por el investigador, con los requisitos del protocolo de estudio matriz 4.Voluntad y capacidad para cumplir con las visitas programadas, planes de tratamiento y cualquier otro procedimiento del estudio 5.Consentimiento informado por escrito obtenido antes de incluirlos en el estudio de continuación. ?Si el consentimiento no puede ser expresado por escrito, deberá ser documentado y atestiguado formalmente, idealmente a través de un testigo independiente de confianza. |
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E.4 | Principal exclusion criteria |
1. Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. 2. Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy. 3. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study. 4. 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 hcG laboratory test. 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib. Male patients must use highly effective contraception during the study and for 30 days after the final dose of nilotinib. Other exclusion criteria as defined in the protocol apply. |
1.Pacientes a los que se les haya retirado permanentemente el tratamiento del estudio con nilotinib en el estudio matriz por toxicidad inaceptable, no cumplimiento con los procedimientos del estudio, retirada del consentimiento o cualquier otro motivo. 2.Pacientes que hayan participado en un ensayo de combinación patrocinado por Novartis donde nilotinib fue dispensado en combinación con otra medicación del estudio y aún estén recibiendo la terapia de combinación. 3.Pacientes que actualmente estén recibiendo tratamiento con algunas medicaciones que tengan potencial de prolongación del intervalo QT o de inducir Torsade de Pointes y que el tratamiento no pueda ser suspendido de forma segura por lo menos una semana antes del tratamiento con nilotinib o cambiado a una medicación distinta antes de iniciar el tratamiento con nilotinib y durante todo el estudio (véase Suplemento 1 para el enlace de la lista de agentes que prolongan el intervalo QT). 4.Pacientes embarazadas o en periodo de lactancia, donde el embarazo se define como el estado de una mujer después de la concepción y hasta el final de la gestación, confirmado con un test de laboratorio hCG positivo. 5.Mujeres físicamente fértiles, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, excepto en el caso de que utilicen métodos anticonceptivos altamente eficaces durante el estudio y durante los 30 días después de la dosis final de nilotinib. Los pacientes varones deberán utilizar métodos anticonceptivos altamente eficaces durante el estudio y durante 30 días después de la dosis final de nilotinib. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients receiving nilotinib |
Número de pacientes que reciban nilotinib |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
throughout the study |
Los datos se utilizarán únicamente para resumen descriptivo de los pacientes que continúen con nilotinib, cuando proceda, durante la realización del estudio |
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E.5.2 | Secondary end point(s) |
Frequency and nature of serious adverse events |
Frecuencia y naturaleza de los acontecimientos adversos graves |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
throughout the study |
Los AAGs de la base de datos de seguridad serán revisados y notificados como parte de las actividades regulares de farmacovigilancia. |
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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 | 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 | 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
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 |
Argentina |
Austria |
Brazil |
Canada |
China |
Denmark |
Egypt |
Germany |
Hong Kong |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Poland |
Singapore |
Slovakia |
Spain |
Sweden |
Taiwan |
Thailand |
United Kingdom |
United States |
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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
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Patients will continue to be treated until they are no longer benefiting from nilotinib treatment, develop unacceptable toxicities, withdraw consent, are non-compliant with the protocol, the investigator feels it is no longer in the patient?s best interest to continue nilotinib therapy or the patient dies, whichever comes first. A patient will reach the end of the roll-over study when nilotinib treatment is permanently discontinued. |
El final del estudio se define como 10 años de duración o cuando todos los pacientes de este estudio hayan suspendido permanentemente el tratamiento con nilotinib y se haya realizado la visita de final de tratamiento para cada paciente, lo que ocurra primero. |
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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 | 10 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 10 |