E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Untreated Metastatic Colorectal Cancer |
Cáncer colorrectal metastásico previamente no tratado |
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E.1.1.1 | Medical condition in easily understood language |
Untreated Metastatic Colorectal Cancer |
Cáncer colorrectal metastásico previamente no tratado |
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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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 objectives of the study is to assess whether the addition of oral veliparib to FOLFIRI will improve progression-free survival (PFS) in subjects with metastatic colorectal cancer (mCRC). |
El objetivo primario del estudio es valorar si la adición de veliparib ora a FOLFIR mejorara la progresión libre de enfermedad en pacientes con cáncer colorectal metastásico |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study is to assess overall survival (OS), objective response rate (ORR), safety, and tolerability. |
El Objetivo secundario del estudio es valorar la supervivencia global del estudio y la tasa de respuesta objetiva, seguridad y tolerabilidad |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic substudy: optional blood test Pharmacodynamic substudies: blood tests and tissue if available |
Subestudio farmacogenético: muestra de sangre opcional Subestudio de Farmacodinamia: muestra de sangre y de tejido si esta disponible |
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E.3 | Principal inclusion criteria |
? ? 18 years of age; ? Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum; ? At least 1 unresectable lesion on a CT scan that is measurable as defined by RECIST, Version 1.1; ? ECOG performance score of 0 or 1; ? Adequate hematologic, renal and hepatic function. |
? Edad de 18 años. ? Adenocarcinoma del colon o del recto, metastásico, confirmado histológica o citológicamente; ? Como mínimo, 1 lesión irresecable en una TC que sea mensurable según las definiciones de los RECIST, versión 1.1; ? Estado funcional ECOG de 0 o 1; ? Función hematológica, renal y hepática adecuada |
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E.4 | Principal exclusion criteria |
? Prior anti-cancer treatment for metastatic colorectal cancer; ? Prior exposure to PARP inhibitors; ? The last course of adjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence; ? Any Clinically significant and uncontrolled major medical condition; ? Subject is pregnant or lactating; ? Any medical condition, which in the opinion of the study Investigator, places the subject at an unacceptably high risk for toxicities. ? For those receiving bevacizumab, standard medical exclusionary conditions apply. |
? Tratamiento oncológico previo por cáncer colorrectal metastásico; ? Exposición previa a inhibidores de la PARP; ? El último ciclo de la quimioterapia adyuvante debe haber finalizado > 12 meses antes de la recidiva del cáncer colorrectal; ? Cualquier condición clínica significativa y situación no contralada ? Pacientes embarazadas o en periodo de lactancia ? Cualquier otro condición en cuya opinión del investigador del estudio, considere que el paciente tiene riesgo alto inaceptable de toxicidad ? Para los que recibieron bevacizumab, se aplican las condiciones de exclusión médicas estándar. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-Free Survival (PFS) |
Enfermedad libre de progresión (ELP) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
PFS will be defined as the number of days from date of randomization to the date of earliest disease progression or death. |
La Enfermedad libre de progresión (ELP) será definida como el número de días desde que se aleatoriza a un paciente hasta la fecha en la que la progresión progresa o el paciente fallece |
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E.5.2 | Secondary end point(s) |
Overall survival (OS) and objective response rate (ORR) |
Supervivencia Global (SG) y tasa de respuesta objetiva (RO) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
OS will be defined as the number of days from the date of randomization to the date of death. ORR will be defined as the proportion of subjects with objective response. |
La Supervivencia global (SG) sera definida como él número de días desde la aleatorización hasta la fecha de fallecimiento. La tasa de respuesta objetiva (RO), será definida como la proporción de pacientes con respuesta objetiva |
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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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 |
Performance Status (ECOG) |
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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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Austria |
Belgium |
France |
Germany |
Hungary |
Russian Federation |
Spain |
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
|
The end-of-study is defined as the date of last subject's last visit. The sponsor may also end the study upon confirmation that the primary endpoint was statistically met. |
El final del estudio es definido como la fecha de la última visita del último paciente. El promotor puede también finalizar el estudio después de la confirmación de que el criterio de valoración principal fue recibido estadísticamente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |