E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Newly diagnosed, untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer |
Carcinoma epitelial seroso de ovario, tubárico o peritoneal primario de alto grado en estadio III o IV no tratado previamente. |
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E.1.1.1 | Medical condition in easily understood language |
Ovarian cancer or ovarian neoplasm |
Cáncer de ovario o neoplasia de ovario |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 the study is to evaluate whether progression-free survival (PFS) is prolonged when veliparib is added to standard platinum-based chemotherapy and then continued as maintenance in both the whole subject population, as well as a more selective cohort of subjects with BRCA-deficient tumors |
El objetivo principal del estudio es evaluar si la SSP(Supervivencia sin progresión) se prolonga cuando se añade veliparib a la quimioterapia convencional a base de platino (carboplatino/paclitaxel) y se continúa después como tratamiento de mantenimiento, en la población completa de pacientes, así como en una cohorte más selectiva de pacientes con tumores deficientes en BRCA |
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E.2.2 | Secondary objectives of the trial |
The primary objective of the study is to evaluate whether progression-free survival (PFS) is prolonged when veliparib is added to standard platinum-based chemotherapy and then continued as maintenance in both the whole subject population, as well as a more selective cohort of subjects with BRCA-deficient tumors |
El objetivo principal del estudio es evaluar si la SSP(Supervivencia sin progresión) se prolonga cuando se añade veliparib a la quimioterapia convencional a base de platino (carboplatino/paclitaxel) y se continúa después como tratamiento de mantenimiento, en la población completa de pacientes, así como en una cohorte más selectiva de pacientes con tumores deficientes en BRCA |
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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 and pharmacodynamic substudy - optional blood and tissue tests respectively |
Subestudios farmacogético y farmacodinámico, pruebas opcionales de sangre y tejido respectivamente |
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E.3 | Principal inclusion criteria |
"Subject must be ? 18 years of age High-grade serous adenocarcinoma Willing to undergo testing for gBRCA Eastern Cooperative Oncology Group performance status of 0, 1, or 2" |
?Las pacientes deben tener ? 18 años de edad y adenocarcinoma seroso de alto grado Deberán aceptar que se le realice una prueba de gBRCA Estado funcional del ECOG (Eastern Cooperative Oncology Group) de 0, 1 o 2? |
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E.4 | Principal exclusion criteria |
"Following histologic cell types are ineligible: endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor. Synchronous primary endometrial cancer, or a past history of endometrial cancer. Prior radiotherapy to any portion of the abdominal cavity or pelvis Clinically significant uncontrolled condition(s), including but not limited to: Bowel obstruction or gastric outlet obstruction. History or evidence upon physical examination of central nervous system (CNS) disease. " |
No son elegibles los siguientes tipos celulares histológicos: adenocarcinoma endometrioide, carcinosarcoma, carcinoma indeferenciado, adenocarcinoma epitelial mixto, adenocarcinoma sin especificar, adenocarcinoma mucinoso, adenocarcinoma de células claras, adenocarcinoma seroso de bajo grado, carcinoma de células transicionales o tumor de Brenner maligno. Cáncer endometrial primario sincrónico o antecedentes de cáncer de endometrio Radioterapia previa en alguna parte de la cavidad abdominal o de la pelvis. Enfermedad no controlada clínicamente relevante, incluyendo pero no limitado a: obstrucción intestinal o pilórica. Historial o evidencia de trastornos del sistema nervioso central (SNC), |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival in both the whole subject population, as well as a more selective cohort of subjects with BRCA-deficient tumors |
Supervivencia sin progresión en la población completa de pacientes, así como una cohorte más selectiva de pacientes con tumores deficientes en BRCA |
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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 the date that the subject was randomized to the date the subject experiences an event of disease progression, according to RECIST criteria version 1.1 (as determined by the Investigator) or to the date of death (all causes of mortality) if disease progression is not reached |
La supervivencia sin progresión (SSP) se define como el número de días desde que el paciente es aleatorizado hasta la fecha en la que la paciente experimenta progresión de la enfermedad, de acuerdo a los criterios RECIST versión 1.1 (determinados por el investigador) o hasta la fecha de muerte (todas las causas de mortalidad) si la progresión de la enfermedad no se alcanza. |
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E.5.2 | Secondary end point(s) |
PFS with veliparib in combination with chemotherapy versus chemotherapy alone, overall survival (OS), safety, and Patient Reported Outcomes |
SSP con veliparib en combinación con quimioterapia frente a quimioterapia sola, supervivencia global (SG), seguridad y Cuestionarios de Resultados comunicados por los pacientes (RCP). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As per protocol |
Como descrito en el protocolo |
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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 | 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) | 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 | Yes |
E.8.1.2 | Open | No |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 |
Israel |
Japan |
Korea, Democratic People's Republic of |
New Zealand |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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LVLS |
Ultima visista del ultimo paciente |
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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 | 4 |
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 | 4 |