E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anaplastic lymphoma kinase (ALK)-positive or rearranged during transfection (RET)-positive cancer |
Tumores positivos para quinasa del linfoma anaplásico (ALK) o reordenación durante la transfección (RET) |
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E.1.1.1 | Medical condition in easily understood language |
ALK positive cancer is any type of cancer that has a change in the ALK gene. RET positive cancer is any type of cancer that has a change in the RET gene. |
El cáncer ALK positivo es cualquier tipo de cáncer que tiene un cambio en el gen ALK. El cáncer RET positivo es cualquier tipo de cáncer que tiene un cambio en el gen RET. |
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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 | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure |
Ofrecer tratamiento continuado con alectinib o crizotinib, según sea el caso, a pacientes con tumores ALK o RET positivo que han sido incluidos previamente en un estudio de alectinib promocionado por Roche y que continúan obteniendo beneficio clínico del tratamiento con alectinib o crizotinib en el momento de finalizar el estudio original. |
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E.2.2 | Secondary objectives of the trial |
•To assess long-term safety of alectinib therapy |
Evaluar la seguridad a largo plazo del tratamiento con alectinib. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible -Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form -Ability and willingness to comply with the protocol, in the investigator's judgment -For women who are not postmenopausal (>=12 months of non−therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug. -For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug. |
- Pacientes incluidos en un ensayo clínico de alectinib promocionado por Roche que estén obteniendo beneficio clínico del tratamiento con alectinib o crizotinib en el momento de terminar el estudio original y en los que no sea posible cambiar el tratamiento del estudio por el fármaco disponible comercialmente. - Disponer de datos en el momento de la terminación del estudio requeridos en el estudio original, incluyendo datos de eficacia y seguridad, registrados en el cuaderno de recogida de datos electrónico. - Capacidad y disposición para cumplir los requisitos del protocolo, de acuerdo con el criterio del investigador -Las mujeres que no se encuentren en fase postmenopáusica (amenorrea no inducida terapéuticamente durante 12 meses) o que no estén esterilizadas quirúrgicamente (con extirpación de ovarios y/o útero) deben comprometerse a practicar la abstinencia sexual o a utilizar uno o varios métodos anticonceptivos combinados que tengan una tasa de fallos de 1% al año durante el período de tratamiento y como mínimo hasta 3 meses después de que reciban la última dosis del fármaco del estudio. -Los varones deben comprometerse a practicar la abstinencia sexual o a utilizar un método anticonceptivo que proporcione una tasa de fallos 1% al año, durante el período de tratamiento y como mínimo hasta 3 meses después de la administración de la última dosis del fármaco del estudio. |
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E.4 | Principal exclusion criteria |
-Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study -Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study -Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation -Pregnant or breastfeeding women -Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study -Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator -Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib -Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the patient before trial entry |
- Ausencia de beneficio clínico en el estudio original evidenciada durante la fase de selección de este estudio de extensión - Interrupción permanente del tratamiento con alectinib o crizotinib, por el motivo que sea, durante el estudio original o antes de administrar la primera dosis del fármaco del estudio en el estudio de extensión. - Evidencia de un acontecimiento adverso que requiera la interrupción permanente del tratamiento, según lo estipulado en el protocolo del estudio original. - Mujeres embarazadas o en período de lactancia. - Acontecimientos adversos graves en curso que no hayan remitido al valor basal o a grado 1 antes de la administración de la primera dosis del tratamiento del estudio en el estudio de extensión. -Interrupción del tratamiento durante más de 21 días debido a un acontecimiento adverso, desde la administración de la última dosis de alectinib o crizotinib en el estudio original. Los acontecimientos adversos en curso que requieran la interrupción temporal del tratamiento deben haber remitido al grado basal o haberse estabilizado sin que se requieran más interrupciones del tratamiento, de acuerdo con el criterio del investigador. -Uso de potentes inhibidores o inductores del citocromo P450 3A en los 14 días previos a la administración de la primera dosis del tratamiento en este estudio y durante el tratamiento con crizotinib. -Cualquier circunstancia psicológica, familiar, sociológica o geográfica que impida potencialmente el cumplimiento de los requisitos del protocolo del estudio y/o los procedimientos de seguimiento; estas situaciones se deben considerar con el paciente antes de su inclusión en el estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Not applicable |
-No aplica |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
-Not applicable |
-No aplica |
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E.5.2 | Secondary end point(s) |
1. Incidence of serious and non-serious adverse events and adverse events of special interest 2. Selected safety laboratory test measurements 3. Number of Deaths occurring on study |
1. Incidencia de acontecimientos adversos graves y no graves y eventos adversos de interés especial 2. Medidas seleccionadas de pruebas de laboratorio de seguridad 3. Número de muertes ocurridas en el estudio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-3. Throughout the study |
1-3. A lo largo del estudio |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure |
Ofrecer tratamiento continuado con alectinib o crizotinib, según sea el caso, a pacientes con tumores ALK o RET positivo que han sido incluidos previamente en un estudio de alectinib promocionado por Roche y que continúan obteniendo beneficio clínico del tratamiento con alectinib o crizotinib en el momento de finalizar el estudio original. |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
rollover study (to offer continious treatment option for patents from parent studies) |
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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 | Yes |
E.8.2.3.1 | Comparator description |
Crizotinib (Xalkori) |
Crizotinib (Xalkori) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
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 |
France |
Italy |
Korea, Republic of |
Russian Federation |
Spain |
Taiwan |
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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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The study will end when the last patient has completed the safety follow-up visit 4 weeks after the last dose of study drug. Because of the nature of the study, the total length of study will not be estimated. |
El estudio terminará cuando el último paciente haya completado la visita de seguimiento de seguridad 4 semanas después de la administración de la última dosis del fármaco del estudio. |
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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 | 7 |
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 | 7 |