E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic colorectal cancer |
Cancer colorrectal mestastásico |
|
E.1.1.1 | Medical condition in easily understood language |
Colorectal cancer |
Cancer colorrectal |
|
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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
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 |
The primary objective of this study is to collect additional safety data during treatment with trifluridine / tipiracil in patients with a pretreated mCRC. |
El objetivo principal de este estudio es recopilar datos de seguridad adicionales durante el tratamiento con trifluridina/tipiracil en pacientes con cáncer colorrectal metastásico (CCRm) tratado previamente. |
|
E.2.2 | Secondary objectives of the trial |
- Progression free survival (PFS) based on Investigator assessment - Quality of life (QoL) using the questionnaires EQ-5D and EORTC QLQ-C30 |
-Supervivencia sin progresión (SSP) basada en la evaluación del investigador -Calidad de vida (CdV) utilizando los cuestionarios EQ-5D y EORTC QLQ-C30 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or Female participant aged ≥18 years old - Has definitive histologically confirmed adenocarcinoma of the colon or rectum - Has metastatic lesion(s). - Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period - Is able to take medications orally (i.e., no feeding tube). - Has adequate organ function - Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must alsouse a barrier method. |
-Participantes hombres o mujeres de 18 o más años de edad. -Adenocarcinoma histológicamente confirmado de colon o recto -Lesión(es) metastásica(s). -Ha recibido como mínimo 2 líneas previas de quimioterapia estándar para CCRm (incluyendo fluoropirimidinas, irinotecán, oxaliplatino, un anticuerpo monoclonal anti-VEGF y como mínimo uno de los anticuerpos monoclonales anti-EGFR en pacientes sin mutación RAS) y es resistente a estas quimioterapias o no las tolera o no es apto para estas quimioterapias. -Un estado funcional de 0 o 1 según baremo del Grupo Oncológico Cooperativo de la Costa Este (ECOG) durante el período de selección. -Es capaz de tomar medicamentos por vía oral (es decir, no a través de una sonda de alimentación). -Tiene una función orgánica adecuada -Las mujeres en edad fértil deben haber obtenido un resultado negativo en una prueba de embarazo en sangre realizada durante los 7 días anteriores al primer día de administración del fármaco del estudio. Las mujeres participantes en edad fértil y los participantes varones con parejas en edad fértil deben comprometerse a utilizar un método anticonceptivo altamente eficaz durante el estudio y 6 meses después de la suspensión de la medicación del estudio. Las mujeres y parejas femeninas que usen anticonceptivos hormonales también deben utilizar un método de barrera. |
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E.4 | Principal exclusion criteria |
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study - Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil - Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil - Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption - Has certain serious illness or medical condition(s) described in the protocol - Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration - Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity). |
- Mujer en período de embarazo o lactancia o con posibilidades de quedarse embarazada durante el estudio. - Elegible para ser incluido en otro estudio clínico en curso disponible con trifluridina/tipiracil. - Ha recibido trifluridina/tipiracil previamente o hipersensibilidad al principio activo o a alguno de los excipientes de trifluridina/tipiracil. - Problemas congénitos raros de intolerancia a la galactosa, deficiencia de lactasa Lapp o mala absorción de glucosa-galactosa. - Enfermedad grave o afección médica grave descritas en el protocolo - Ha recibido otros tratamientos previos como: cirugía mayor, terapia antineoplásica, radioterapia o ha participado en otro estudio intervencionista en los plazos previos a la primera administración del fármaco descritos en el protocolo. - Toxicidad sin resolver de Grado 2 o superior según los Criterios terminológicos comunes para la evaluación de acontecimientos adversos (CTCAE) atribuida a terapias anteriores (sin incluir anemia, alopecia, pigmentación cutánea y neurotoxicidad inducida por platino). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability assessed by: - Incidence of Adverse Events - Laboratory tests: haematology, blood biochemistry, urinalysis - Physical examination and performance status (ECOG) - Vital signs: blood pressure, heart rate, body temperature, body weight |
Seguridad y tolerabilidad evaluada mediante: - incidencia de acontecimientos adversos, - análisis clínicos de laboratorio: hematología, bioquímica sanguínea, análisis de orina, - exploraciones físicas y estado funcional ECOG, - constantes vitales: presión arterial, frecuencia cardiaca, temperatura corporal, peso |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Incidence of Adverse Events: all over the study Laboratory tests, physical examination, performance status, vital signs: at baseline, every 4 weeks during study treatment from cycle 2, at withdrawal visit. |
- incidencia de acontecimientos adversos: a lo largo de todo el estudio, - análisis clínicos de laboratorio, exploraciones físicas,estado funcional, constantes vitales: al inicio, cada 4 semanas durante el periodo de tratamiento desde el ciclo 2 y en la visita de fin de estudio |
|
E.5.2 | Secondary end point(s) |
- Progression free survival (PFS) - Quality of life (QoL) using the questionnaires |
- Supervivencia sin progresión (SSP) - Calidad de vida (CdV) utilizando los cuestionarios EQ-5D y EORTC QLQ-C30 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Tumour assessment based on general practices and standard of care of the site. - Quality of Life: at baseline, every 4 weeks during study treatment from cycle 2, at withdrawal visit (if not performed within the previous 4 weeks). |
- Evaluación tumoral según la práctica general y las normas asistenciales del centro - Calidad de vida: al inicio, cada 4 semanas durante el periodo de tratamiento desde el ciclo 2 y en la visita de fin de estudio (si no se ha hecho en las 4 semanas previas) |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of life measurements and Medical Resource Utilization (MRU) data |
Evaluación de la calidad de vida y datos de utilización de Recursos Médicos (URM) |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 |
Argentina |
Australia |
Belgium |
Brazil |
Bulgaria |
Croatia |
France |
Ireland |
Italy |
Poland |
Portugal |
Romania |
Slovakia |
Slovenia |
Spain |
Switzerland |
Turkey |
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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
|
LVLS |
Ultima Visita Ultimo Paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |