E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BRCA Mutated Ovarian Cancer Patients |
Pazienti con tumore ovarico con BRCA mutato |
|
E.1.1.1 | Medical condition in easily understood language |
Ovarian cancer |
Tumore ovarico |
|
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast 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. |
Fornire un trattamento dello studio continuo ai pazienti che continuano a ricevere un beneficio al termine di una sperimentazione clinica, monitorando allo stesso tempo sicurezza e tollerabilità. |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
non applicabile |
|
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. Fornitura di ICF scritto firmato e datato. 2. Il paziente attualmente sta avendo un beneficio clinico, come giudicato dallo sperimentatore, dal proseguimento del trattamento in uno studio originario AZ utilizzando un medicinale AstraZeneca (AZ) che ha raggiunto i suoi endpoint o che si è altrimenti arrestato. 3. Il paziente ha partecipato a uno studio oncologico precedente con un medicinale AZ in cui ha ricevuto olaparib e continua ad avere un beneficio clinico dal trattamento; lo studio precedente può essere uno studio in aperto o in cieco, con apertura del cieco alla chiusura dello studio. |
|
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 Tossicità in corso, non risolta, di grado 3 o superiore che richiede l'interruzione del trattamento al momento della conclusione dello studio originario. 2 Attualmente in trattamento con farmaci vietati. 3 Arruolamento contemporaneo a qualsiasi altro tipo di ricerca medica ritenuta non compatibile scientificamente o medicalmente con questo studio. 4 Interruzione definitiva dallo studio originario a causa di tossicità o progressione della malattia. 5 Accesso locale al farmaco disponibile in commercio senza alcun costo per il paziente, consentito dalla normativa locale. |
|
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. |
SAE e AESI segnalati fino ai 30 giorni successivi all’ultima dose del farmaco in studio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study. |
per tutta la durata dello studio |
|
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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 54 |
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 | Information not present in EudraCT |
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 |
Korea, Republic of |
Russian Federation |
Taiwan |
Turkey |
United States |
Bulgaria |
France |
Germany |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 9 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |