E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, Prostate cancer, Endometrial cancer
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E.1.1.1 | Medical condition in easily understood language |
Ovarian cancer, Breast cancer, gBRCA mutated metastatic pancreatic cancer, prostate cancer, Endometrial cancer
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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 | 10006187 |
E.1.2 | Term | Breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 27.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033605 |
E.1.2 | Term | Pancreatic cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 | 10016180 |
E.1.2 | Term | Fallopian tube cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014733 |
E.1.2 | Term | Endometrial 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 provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability. |
Fournir un approvisionnement ininterrompu en traitement expérimental aux patients qui continuent à en retirer des bénéfices à la fin d’une étude clinique, tout en évaluant la sécurité d’emploi et la tolérance |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicable |
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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 Remise d’un formulaire de consentement éclairé écrit, signé et daté. 2 De l’avis de l’investigateur, le patient retire actuellement un bénéfice clinique en continuant le traitement d’une étude mère d’AstraZeneca (AZ) portant sur un traitement expérimental qui a rempli les critères d’évaluation ou dont l’administration est terminée. 3 Patient ayant participé à une précédente étude en oncologie portant sur un composé d’AZ, dans laquelle il a reçu de l’olaparib et qui continue à en retirer un bénéfice clinique ; l’étude précédente peut être une étude menée en ouvert ou en aveugle, avec levée de l’aveugle à la fin de l’étude.
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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. (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, RECIST] progression or clinical progression). 5 Local access to commercially-available drug at no cost to the patient, as permitted by local/ country regulation. |
1 Toxicité actuelle non résolue, de grade 3 ou supérieur nécessitant l’interruption du traitement au moment de l’arrêt de l’étude mère. 2 Le patient reçoit actuellement un ou plusieurs traitement(s) interdits. 3 Patient inclus simultanément dans tout autre type de recherche médicale jugée non compatible avec cette étude, d’un point de vue scientifique ou médical. 4 Arrêt définitif de l’étude mère en raison d’une toxicité ou d’une progression de la maladie. (augmentation de la gravité de la maladie à l’étude et/ou augmentation des symptômes de l’état d’un patient attribuable à la maladie, tel qu’évalué et documenté par l’investigateur. La progression définie par le médecin peut être une progression radiologique [par ex. selon les critères RECIST] ou une progression clinique). 5 Autorisation par la réglementation locale/nationale d’un accès gratuit pour le patient au médicament commercialement disponible
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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. |
EIG et EIIP signalés jusqu’à 30 jours après la dernière dose du médicament à l’étude.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study. |
Tout au long de l'étude |
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E.5.2 | Secondary end point(s) |
Not applicable |
Non applicable |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Non applicable |
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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
| 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 | 60 |
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 |
Taiwan |
Brazil |
Canada |
China |
Israel |
Korea, Republic of |
Russian Federation |
United Kingdom |
United States |
Belgium |
Bulgaria |
Czechia |
Denmark |
Finland |
France |
Germany |
Hungary |
Italy |
Poland |
Portugal |
Slovenia |
Spain |
Türkiye |
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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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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 | 6 |
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 |