E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BRCA Mutated Ovarian Cancer Patients |
Pacientes con cáncer de ovario con mutación de BRCA |
|
E.1.1.1 | Medical condition in easily understood language |
Ovarian Cancer |
Cáncer de ovario |
|
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 | 10033128 |
E.1.2 | Term | Ovarian cancer |
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 |
To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability. |
Proporcionar de forma continuada el tratamiento del estudio a los pacientes que sigan beneficiándose del medicamento al término de su ensayo clínico, vigilando, a la vez, la seguridad y la tolerabilidad. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 Provision of signed and dated, written ICF. 2 Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped. 3 Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close. |
1 El paciente otorgan su Consentimiento Informado, firmado y fechado. 2 En opinión del investigador, el paciente se está beneficiando clínicamente de la continuación del tratamiento con olaparib de AstraZeneca (AZ) en otro estudio original de AZ que ya ha alcanzado sus criterios de valoración o que se ha suspendido por otra razón. 3 El paciente está participando en un estudio en oncología previo en el que ha recibido olaparib de AZ y continúa mostrando beneficio clínico de dicho tratamiento; el estudio previo puede ser de tipo abierto o ciego, con apertura en el momento de su cierre. |
|
E.4 | Principal exclusion criteria |
1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2 Currently receiving treatment with any prohibited medication(s). 3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 4 Permanent discontinuation from the parent study due to toxicity or disease progression. 5 Local access to commercially-available drug at no cost to the patient is permitted by local regulation. |
1 Toxicidad de Grado 3 o superior aún en curso, no resuelta, que precisó la interrupción del tratamiento en ocasión de la terminación del estudio original. 2 En tratamiento actualmente con cualquier medicamento(s) prohibido por el estudio. 3 Participando actualmente en otro tipo de investigación médica que no se considera compatible, científica o médicamente, con este estudio. 4 Salida permanente del estudio original por toxicidad o progresión de la enfermedad. 5 Las normativas locales permiten el acceso al fármaco disponible comercialmente sin coste para la paciente |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SAEs and AESIs reported until 30 days after the last dose of study drug. |
AAG y AAEI comunicados hasta 30 días después de la última dosis del medicamento del estudio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study. |
A lo largo del estudio. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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) | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 6 |
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 |
Canada |
United States |
Bulgaria |
Hungary |
Italy |
Poland |
Spain |
United Kingdom |
Czechia |
|
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 |
Última 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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 10 |
E.8.9.2 | In all countries concerned by the trial months | 3 |