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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003777-26 | EudraCT Number |
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The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
ROSY-O is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib | Experimental | Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | 300 mg olaparib (2×150 mg tablets) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety follow up | Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug. | Baseline up to approximately 10 years |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects with historically diagnosed relapsed high grade serious or high grade endometrioid ovarian cancer; Patients with HER2-ve metastatic breast cancer with germline or somatic BRCA mutations.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Boca Raton | Florida | 33486 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| Towson |
| Maryland |
| 21204 |
| United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Minneapolis | Minnesota | 55407 | United States |
| Research Site | Basking Ridge | New Jersey | 07920 | United States |
| Research Site | Hackensack | New Jersey | 07601 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Research Site | Willow Grove | Pennsylvania | 19090 | United States |
| Research Site | Providence | Rhode Island | 02905 | United States |
| Research Site | Germantown | Tennessee | 38138 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Plovdiv | 4004 | Bulgaria |
| Research Site | Sofia | 1330 | Bulgaria |
| Research Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Research Site | Kingston | Ontario | K7L 2V7 | Canada |
| Research Site | Mississauga | Ontario | L5M 2N1 | Canada |
| Research Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Montreal | Quebec | H1T 2M4 | Canada |
| Research Site | Montreal | Quebec | H2X 0A9 | Canada |
| Research Site | Montreal | Quebec | H3T 1E2 | Canada |
| Research Site | Montreal | Quebec | H4A-3J1 | Canada |
| Research Site | Québec | Quebec | G1S 4L8 | Canada |
| Research Site | Changchun | 130021 | China |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | Olomouc | 779 00 | Czechia |
| Research Site | Ostrava Poruba | 708 52 | Czechia |
| Research Site | Prague | 128 08 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Kuopio | 70210 | Finland |
| Research Site | Lille | 59020 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Plérin | 22190 | France |
| Research Site | Villejuif | 94800 | France |
| Research Site | Dresden | 1307 | Germany |
| Research Site | Budapest | 1032 | Hungary |
| Research Site | Budapest | 1122 | Hungary |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Jerusalem | 91031 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Ramat Gan | 5265601 | Israel |
| Research Site | Tel Aviv | 6423906 | Israel |
| Research Site | Ancona | 60020 | Italy |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Brescia | 25123 | Italy |
| Research Site | Candiolo | 10060 | Italy |
| Research Site | Catania | 95126 | Italy |
| Research Site | Lecce | 73100 | Italy |
| Research Site | Lecco | 23900 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20141 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Torino | 10128 | Italy |
| Research Site | Verona | 37134 | Italy |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Grzepnica | 72-003 | Poland |
| Research Site | Lublin | 20-090 | Poland |
| Research Site | Olsztyn | 10-561 | Poland |
| Research Site | Poznan | 60-569 | Poland |
| Research Site | Poznan | 61-866 | Poland |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Porto | 4200-072 | Portugal |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Ljubljana | 1000 | Slovenia |
| Research Site | Seoul | 01812 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 06273 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 6351 | South Korea |
| Research Site | Badalona | 08916 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Barcelona | 8907 | Spain |
| Research Site | Barcelona | ?08041 | Spain |
| Research Site | Córdoba | 14004 | Spain |
| Research Site | Donostia / San Sebastian | 20014 | Spain |
| Research Site | Granada | 18014 | Spain |
| Research Site | Madrid | 28027 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Pamplona | 31008 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Vigo | 36312 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Research Site | Lund | 22185 | Sweden |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Istanbul | 34093 | Turkey (Türkiye) |
| Research Site | Şahinbey | 27310 | Turkey (Türkiye) |
| Research Site | Birmingham | B18 7QH | United Kingdom |
| Research Site | Edinburgh | EH4 2XU | United Kingdom |
| Research Site | Glasgow | G12 OYN | United Kingdom |
| Research Site | Hull | HU16 5JQ | United Kingdom |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Taunton | TA1 5DA | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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