E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cMET-dependent malignancies |
neoplásicas malignas dependientes de cMET |
|
E.1.1.1 | Medical condition in easily understood language |
cMET-dependent malignancies |
neoplásicas malignas dependientes de cMET |
|
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 | 19.1 |
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 evaluate long term safety data (SAEs and AEs) |
Evaluar los datos de seguridad a largo plazo (AAGs y AAs) |
|
E.2.2 | Secondary objectives of the trial |
To evaluate clinical benefit as assessed by the investigator |
Evaluar el beneficio clínico, determinado por el investigador. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patient is currently receiving treatment with INC280 monotherapy 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. 2.Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 3.Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 4.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. |
1. Pacientes que actualmente estén recibiendo tratamiento con INC280 en monoterapia dentro de un estudio patrocinado por Novartis que haya cumplido los requisitos del objetivo principal y que, a criterio del investigador, podrían beneficiarse de la continuación del tratamiento. 2. Pacientes que hayan demostrado cumplimiento, determinado por el investigador, con los requisitos del protocolo del estudio principal. 3. Voluntad y capacidad para cumplir con las visitas programadas, planes de tratamiento y cualquier otro procedimiento del estudio. 4. Consentimiento informado por escrito obtenido antes de la inclusión en el estudio de continuación y de recibir la medicación del estudio. Si el consentimiento no puede expresarse por escrito, deberá ser atestiguado y documentado formalmente, idealmente por un testigo independiente de confianza. |
|
E.4 | Principal exclusion criteria |
1.Patient has been previously permanently discontinued from INC280 study treatment in the parent study due to any reason. 2.Patient currently has unresolved toxicities for which INC280 dosing has been interrupted in the parent study (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow INC280 dosing to resume). 3.Pregnant or nursing (lactating) women. 4.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping treatment. Please refer to protocol for further details and additional exclusion criteria |
1. Pacientes a los que se les haya suspendido previamente de forma definitiva el tratamiento del estudio INC280 en el estudio principal, por cualquier motivo. 2. Pacientes que presenten actualmente toxicidades no resueltas por las que les fue suspendida la dosis de INC280 en el estudio principal (los pacientes que cumplan todos los otros criterios de elegibilidad pueden ser incluidos cuando se hayan resuelto las toxicidades para permitir que se reinicie la dosis de INC280). 3. Mujeres embarazadas o en periodo de lactancia. 4. Mujeres físicamente fértiles, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, a no ser que utilicen métodos anticonceptivos altamente eficaces durante la dosis y durante 7 días después de suspender el tratamiento. Por favor refieranse al protocol para mayor información sobre los criterios de exclusion |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of AEs/SAEs |
Frecuencia y severidad de los AAa y AAGs |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
as defined per protocol |
segun lo definido en el protocolo |
|
E.5.2 | Secondary end point(s) |
Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits. |
Proporción de pacientes con beneficio clínico evaluados por el investigador en las visitas programadas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
as defined per protocol |
segun lo definido en el protocolo |
|
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 | 24 |
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 |
Austria |
Belgium |
Czech Republic |
Denmark |
France |
Germany |
Greece |
Italy |
Korea, Republic of |
Netherlands |
Spain |
Sweden |
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 study is expected to remain open for 5 years after the first patient’s first visit in this clinical study or until such time that all enrolled patients no longer need treatment with INC280, whichever comes first. |
Se prevé que el estudio permanezca abierto durante 5 años después de la primera visita del primer paciente o hasta el momento en que todos los pacientes incluidos ya no precisen tratamiento con INC280, lo que ocurra primero. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |