E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
solid tumors or lymphomas, as defined in parent protocol |
Tumores sólidos o linfomas, definidos en el estudio de origen |
|
E.1.1.1 | Medical condition in easily understood language |
Diverse Cancers |
Cánceres diversos |
|
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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055107 |
E.1.2 | Term | Thyroid cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016935 |
E.1.2 | Term | Follicular thyroid cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027105 |
E.1.2 | Term | Medullary thyroid cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066474 |
E.1.2 | Term | Thyroid cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033701 |
E.1.2 | Term | Papillary thyroid cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025315 |
E.1.2 | Term | Lymphoma malignant |
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 |
The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies. |
El objetivo principal es evaluar la seguridad a largo plazo del fármaco(s) del estudio en sujetos participantes en estudios de lenvatinib promovidos por Eisai. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provide signed written informed consent for the roll-over trial 2. Currently enrolled in an Eisai sponsored lenvatinib clinical trial and still receiving at least one of the study drugs from that protocol 3. Currently deriving clinical benefit from at least one of the study drug(s) as determined by the investigator 4. Must be able and willing to comply with the current role-over protocol requirements 5. Continued ability to swallow and retain orally administered study drug(s) 6. Does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels 7. Women of childbearing potential and men with reproductive potential (if specified by the parent study) must be willing to continue to use highly effective methods of contraception control as per local practices of standard of care during the period of the study 8. Women of childbearing potential must have a negative serum pregnancy test at the time of transition to the study and before continuing study drug(s) |
1. Firma del consentimiento informado por escrito para el estudio de extensión. 2. Participa actualmente en un estudio clínico de lenvatinib promovido por Eisai y continúa recibiendo al menos uno de los fármacos del estudio de ese protocolo. 3. Obtiene actualmente beneficio clínico de al menos uno de los fármacos del estudio, según lo determinado por el investigador. 4. Puede y está dispuesto a cumplir los requisitos actuales del protocolo del estudio de extensión. 5. Capacidad continuada para tragar y retener los fármacos del estudio administrados por vía oral. 6. No presenta ninguna anomalía digestiva con importancia clínica que pueda alterar la absorción, como síndrome de malabsorción o resección importante del estómago o intestino. 7. Las mujeres en edad fértil y los varones con capacidad reproductiva (si se especifica en el estudio de origen) deben estar dispuestos a continuar usando métodos anticonceptivos muy eficaces con arreglo a la práctica asistencial local durante el período del estudio. 8. Las mujeres en edad fértil deben tener un resultado negativo en una prueba de embarazo en suero en el momento de la incorporación al estudio y antes de continuar recibiendo el fármaco(s) del estudio. |
|
E.4 | Principal exclusion criteria |
1. Permanent discontinuation of all study drug(s) in the parent trial due to toxicity or disease progression and without clinical benefit 2. Receiving any prohibited medication(s) as described in the parent trial 3. Any unresolved toxicity that meets the criteria for study drug(s) discontinuation or withdrawal criteria from the parent trial at the time of transition to this study 4. Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to the roll-over trial that may interfere with assessment of toxicity 5. Pregnant or lactating female 6. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to the roll-over trial that could interfere with subject's safety in the opinion of the investigator |
1. Suspensión permanente de todos los fármacos del estudio en el estudio de origen debido a toxicidad o progresión de la enfermedad y ausencia de beneficio clínico. 2. Uso de cualquier medicamento prohibido según lo descrito en el estudio de origen. 3. Cualquier toxicidad no resuelta que cumpla los criterios para la suspensión del fármaco(s) del estudio o los criterios para la retirada del estudio de origen en el momento de la incorporación a este estudio. 4. Diabetes no controlada, hipertensión u otros problemas médicos en el momento de la incorporación al estudio de extensión que podrían interferir en la evaluación de la toxicidad. 5. Mujer embarazada o en período de lactancia. 6. Cualquier trastorno médico o psiquiátrico grave preexistente u otras afecciones en el momento de la incorporación al estudio de extensión que en opinión del investigador podrían afectar a la seguridad del sujeto. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety assessments will consist of monitoring and recording all TEAEs, including all Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grades (for both increasing and decreasing severity), and SAEs. Long term safety information will be collected at the time drug is dispensed to the subject. Monitoring of hematology, blood chemistry, and urine values; measurement of vital signs and performance of physical examinations should be performed per local standard of care or as clinically indicated. |
Las evaluaciones de la seguridad consistirán en la vigilancia y registro de todos los AAAT y AAG usando los criterios terminológicos comunes para acontecimientos adversos (CTCAE) v.4.03. Se recopilará información sobre seguridad a largo plazo en el momento de dispensar el fármaco al sujeto. Evaluaciones de hematología, bioquímica y orina; exploraciones físicas periódicas y de constantes vitales, serán realizadas por práctica asistencial habitual o cuando esté clínicamente indicado. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
All assessments for efficacy and safety will be performed as per local standard of care or as clinically indicated. |
Todas las evaluaciones de eficacia y seguridad serán realizadas por práctica asistencial habitual o cuando esté clínicamente indicado. |
|
E.5.2 | Secondary end point(s) |
Not applicable |
No aplicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
No aplicable |
|
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 | 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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 11 |
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 |
Brazil |
France |
Germany |
Italy |
Korea, Republic of |
Netherlands |
Poland |
Romania |
Spain |
Thailand |
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
|
LVLS |
Ultima visita del último paciente |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |