Ovarian CancerPhase 3ROSY-ONCT04421963
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
A Phase 3 study testing Olaparib in people with Ovarian Cancer and Breast Cancer, run by AstraZeneca at 107 sites in 23 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ovarian Cancer, Breast Cancer
- What is being tested?
- Olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 107 sitesin 23 countries
- Study dates
- 4 Aug 2020to 6 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
107 sites in 23 countries.
107 sites in 23 countries
United States14 sites
Research Site
Basking Ridge, New Jersey, 07920
Research Site
Boca Raton, Florida, 33486
Research Site
Detroit, Michigan, 48201
Research Site
Germantown, Tennessee, 38138
Research Site
Hackensack, New Jersey, 07601
Research Site
Houston, Texas, 77030
Research Site
Minneapolis, Minnesota, 55407
Research Site
New York, New York, 10032
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pittsburgh, Pennsylvania, 15224
Research Site
Providence, Rhode Island, 02905
Research Site
The Bronx, New York, 10461
Research Site
Towson, Maryland, 21204
Research Site
Willow Grove, Pennsylvania, 19090
Italy14 sites
Research Site
Ancona, 60020
Research Site
Bologna, 40138
Research Site
Brescia, 25123
Research Site
Candiolo, 10060
Research Site
Catania, 95126
Research Site
Lecce, 73100
Research Site
Lecco, 23900
Research Site
Milan, 20132
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Roma, 00168
Research Site
Torino, 10128
Research Site
Verona, 37134
Spain14 sites
Research Site
Badalona, 08916
Research Site
Barcelona, 08035
Research Site
Barcelona, 8907
Research Site
Barcelona, ?08041
Research Site
Córdoba, 14004
Research Site
Donostia / San Sebastian, 20014
Research Site
Granada, 18014
Research Site
Madrid, 28027
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Pamplona, 31008
Research Site
Valencia, 46026
Research Site
Vigo, 36312
Research Site
Zaragoza, 50009
Canada11 sites
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Mississauga, Ontario, L5M 2N1
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H2X 0A9
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Montreal, Quebec, H4A-3J1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1S 4L8
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
United Kingdom7 sites
Research Site
Birmingham, B18 7QH
Research Site
Edinburgh, EH4 2XU
Research Site
Glasgow, G12 OYN
Research Site
Hull, HU16 5JQ
Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Taunton, TA1 5DA
Czechia6 sites
Research Site
Brno, 625 00
Research Site
Brno, 656 53
Research Site
Olomouc, 779 00
Research Site
Ostrava Poruba, 708 52
Research Site
Prague, 128 08
Research Site
Prague, 150 06
Israel6 sites
Research Site
Haifa, 31096
Research Site
Jerusalem, 91031
Research Site
Jerusalem, 91120
Research Site
Petah Tikva, 49100
Research Site
Ramat Gan, 5265601
Research Site
Tel Aviv, 6423906
Poland6 sites
Research Site
Bialystok, 15-027
Research Site
Grzepnica, 72-003
Research Site
Lublin, 20-090
Research Site
Olsztyn, 10-561
Research Site
Poznan, 60-569
Research Site
Poznan, 61-866
South Korea6 sites
Research Site
Seoul, 01812
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06273
Research Site
Seoul, 06351
Research Site
Seoul, 6351
France4 sites
Research Site
Lille, 59020
Research Site
Lyon, 69373
Research Site
Plérin, 22190
Research Site
Villejuif, 94800
Bulgaria3 sites
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4004
Research Site
Sofia, 1330
Turkey (Türkiye)3 sites
Research Site
Ankara, 06230
Research Site
Istanbul, 34093
Research Site
Şahinbey, 27310
About this study
Official title: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
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.
Read the detailed description
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
- Conditions
- Ovarian Cancer, Breast Cancer
- Being tested
- Olaparib
- Keywords
- HER2-ve metastatic, BRCA mutations, Cancer
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
300 mg olaparib (2×150 mg tablets) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Olaparib | Experimental | Treatment Receives: Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety follow up
Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
Measured: Baseline up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 Aug 2020
- Primary completion6 Apr 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421963
- Sponsor's protocol ID
- D0817C00098
- Other IDs
- 2019-003777-26, 2019
- Acronym
- ROSY-O
- Status last verified
- Jun 2026
- First submitted
- 19 May 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
- ClinicalTrials.gov ID
- NCT04421963
- Acronym / sponsor ID
- ROSY-O / D0817C00098
- Conditions
- Ovarian Cancer, Breast Cancer
- Keywords
- HER2-ve metastatic, BRCA mutations, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 185 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparib | Experimental | Drug: OlaparibTreatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olaparib300 mg olaparib (2×150 mg tablets) twice daily | Drug | Olaparib |
Primary outcome
Safety follow up
Time frame: Baseline up to approximately 10 years
Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
107 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olaparib in people with Ovarian Cancer and Breast Cancer, run by AstraZeneca at 107 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in United States, Italy, Spain, Canada, United Kingdom and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety follow up (time frame: Baseline up to approximately 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.