E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
epithelial ovarian cancer (including fallopian tube or peritoneal cancer) |
cancer de ovario |
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E.1.1.1 | Medical condition in easily understood language |
tumor of the ovary |
tumor de ovario |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061328 |
E.1.2 | Term | Ovarian epithelial cancer |
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 clinically, molecularly and genomically characterize patients with long term and short term disease control on olaparib in terms of: • Somatic BRCA mutation • Homologous recombination repair (HRR) deficiency panel • Genomic sequencing • Immune profile • PI3K/Akt pathway expression • Gene expression |
Caracterizar clínica, molecular y genómicamente a las pacientes con un control de la enfermedad a largo y corto plazo con olaparib en términos de lo siguiente: • Mutación de BRCA somática • Panel de deficiencia de reparación de recombinación homóloga (HRR) • Secuenciación genómica • Perfil inmunológico • Expresión de la vía PI3K/Akt • Expresión genética |
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E.2.2 | Secondary objectives of the trial |
• To define the HRR deficiency profile • Define the level of poly (ADP-ribose) (PAR) expression by immunohistochemistry • To compare the signature of PARP response with the signature of platinum sensitivity which have been previously assessed in patients with long response to platinum based chemotherapy • To assess the signature of PARP response and PARP resistance on different tumour sites • To define how patients take olaparib in the long term setting
Exploratory objectives: • To characterize the tumor profile at disease progression • To assess the pharmacokinetics and pharmacogenomics of olaparib for patients still on treatment • To assess circulating tumor DNA (ctDNA) at the time of response on olaparib and at progression |
• Definir el perfil de déficit de HRR • Definir el nivel de expresión de poli ADP ribosa (PAR) mediante inmunohistoquímica • Comparar la firma de la respuesta de PARP con la firma de la sensibilidad de platino que se haya evaluado previamente en pacientes con una larga respuesta a quimioterapia basada en platino • Evaluar la firma de la respuesta de PARP y la resistencia a PARP en distintos sitios de tumores • Definir cómo los pacientes toman olaparib a largo plazo |
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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 |
To characterize the tumor profile at disease progression. Part of main protocol. |
Caracterizar el perfil del tumor en la progresión de la enfermedad. Parte del protocolo |
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E.3 | Principal inclusion criteria |
Inclusion Criteria: 1. Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer) : • single agent olaparib given for relapsed disease or • single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or • olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or • olaparib combined with other types of therapy 2. Had a durable response to Olaparib defined as patients who have benefited from olaparib for ≥ 2 years. or The control group is patients who had a short duration benefit with Olaparib of less than 3 months in any individual clinical trial/standard of care 3. Ability to understand and the willingness to sign a written informed consent document. 4. Subject is willing and able to comply with scheduled visits, laboratory tests, and other study procedures |
1. Tratamiento previo o actual con olaparib en un ensayo clínico o estándar de atención médica que haya incluido uno de los tratamientos siguientes como ensayo primario para el cáncer epitelial de ovario (incluido el cáncer de trompas de Falopio o peritoneal):
• olaparib como único agente administrado para enfermedad recidivante o bien • olaparib como único agente administrado como tratamiento de mantenimiento después de la respuesta a quimioterapia basada en platino o bien • olaparib combinado con quimioterapia basada en platino y continuado como tratamiento de mantenimiento o bien • olaparib combinado con otros tipos de tratamiento
2. Personas con una respuesta duradera a olaparib, es decir, pacientes que han obtenido beneficios de olaparib durante ≥ 18 meses
o bien
El grupo de control consta de pacientes que han obtenido beneficios de corta duración con olaparib de menos de 6 meses, en un ensayo clínico o estándar de atención médica individual.
3. Capacidad para entender y voluntad para firmar un documento de consentimiento informado.
4. Voluntad y capacidad de la paciente para cumplir con las visitas programadas, las pruebas de laboratorio y otros procedimientos del estudio. |
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E.4 | Principal exclusion criteria |
Exclusion Criteria: 1. Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy 2. Pregnant or breastfeeding women |
1. Cualquier trastorno médico o psiquiátrico grave, agudo o crónico, o anomalía de laboratorio que puedan hacer que el paciente no sea apto para una biopsia 2. Mujeres embarazadas o en período de lactancia |
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E.5 End points |
E.5.1 | Primary end point(s) |
To clinically, molecularly and genomically characterize patients with long term and short term disease control on olaparib in terms of: - Somatic BRCA mutation - Homologous recombination repair (HRR) deficiency panel - Genomic Sequencing - Immune Profile - PI3K/Akt pathway expression - Gene expression |
Caracterizar clínica, molecular y genómicamente a las pacientes con un control de la enfermedad a largo y corto plazo con olaparib en términos de lo siguiente: • Mutación de BRCA somática • Panel de deficiencia de reparación de recombinación homóloga (HRR) • Secuenciación genómica • Perfil inmunológico • Expresión de la vía PI3K/Akt • Expresión genética |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Estimated primary completion date: July 2019 |
Julio 2019 (estimado) |
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E.5.2 | Secondary end point(s) |
- To define the HRR deficiency profile - Define the level of poly (ADP-ribose) (PAR) expression by immunohistochemistry - To compare the signature of PARP response with the signature of platinum sensitivity which have been previously assessed in patient with long response to platinum based chemotherapy - To assess the signature of PARP response and PARP resistance on different tumour sites - To define how patient take olaparib in the long term setting
Exploratory Endpoints - To characterize the tumor profile at disease progression - To assess the pharmacokinetics and pharmacogenomics of olaparib for patients still on treatment - To assess circulating tumor DNA (ctDNA) at the time of response on olaparib and at progression |
• Definir el perfil de déficit de HRR • Definir el nivel de expresión de poli ADP ribosa (PAR) mediante inmunohistoquímica • Comparar la firma de la respuesta de PARP con la firma de la sensibilidad de platino que se haya evaluado previamente en pacientes con una larga respuesta a quimioterapia basada en platino • Evaluar la firma de la respuesta de PARP y la resistencia a PARP en distintos sitios de tumores • Definir cómo los pacientes toman olaparib a largo plazo |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Estimated primary completion date: July 2019 |
Julio 2019 (estimado) |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 |
retrospectivo/prospectivo |
retrospective/prospective |
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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 |
pacientes con beneficio a corto plazo con Olaparib o que estan en tratamiento menos de 3 meses |
patients who had a short duration benefit with Olaparib or are in treatment less than 3 months |
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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
| 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 | 2 |
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 |
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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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End of trial projected to be 4 years after initiation in July 2015 in Canada. This is a study involving patients from several clinical trials who had received olaparib. Sample size will not be based on any a priori considerations of statistical power, but rather on the number of available cases from the different studies. |
Fin del estudio sera 4 años despues de iniciado en Julio 2015 en Canada. Es un estudio en pacientes de varios estudios que han recibido Olaparib. El tamaño de la muestra no sera pre-definido pero se obtendra de los casos disponibles de distintos ensayos |
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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 |