Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
ROSY-O
2 other identifiers
interventional
185
23 countries
107
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 ovarian-cancer
Started Aug 2020
Typical duration for phase_3 ovarian-cancer
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 6, 2027
April 16, 2026
April 1, 2026
6.7 years
May 19, 2020
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Olaparib
EXPERIMENTALTreatment
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed and dated, written ICF.
- 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.
- 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.
You may not qualify if:
- Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- Currently receiving treatment with any prohibited medication(s).
- Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Permanent discontinuation from the parent study due to toxicity or disease progression.
- Local access to commercially-available drug at no cost to the patient is permitted by local regulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (107)
Research Site
Boca Raton, Florida, 33486, United States
Research Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
June 9, 2020
Study Start
August 4, 2020
Primary Completion (Estimated)
April 6, 2027
Study Completion (Estimated)
April 6, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.