Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (ROSY-O)

April 15, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Plovdiv, Bulgaria, 4004
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Research Site
      • Mississauga, Ontario, Canada, L5M 2N1
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
      • Montreal, Quebec, Canada, H4A-3J1
        • Research Site
      • Québec, Quebec, Canada, G1S 4L8
        • Research Site
  • China
      • Changchun, China, 130021
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Brno, Czechia, 625 00
        • Research Site
      • Olomouc, Czechia, 779 00
        • Research Site
      • Ostrava Poruba, Czechia, 708 52
        • Research Site
      • Prague, Czechia, 128 08
        • Research Site
      • Prague, Czechia, 150 06
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
  • Finland
      • Kuopio, Finland, 70210
        • Research Site
  • France
      • Lille, France, 59020
        • Research Site
      • Lyon, France, 69373
        • Research Site
      • Plérin, France, 22190
        • Research Site
      • Villejuif, France, 94800
        • Research Site
  • Germany
      • Dresden, Germany, 1307
        • Research Site
  • Hungary
      • Budapest, Hungary, 1122
        • Research Site
      • Budapest, Hungary, 1032
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Ramat Gan, Israel, 5265601
        • Research Site
      • Tel Aviv, Israel, 6423906
        • Research Site
  • Italy
      • Ancona, Italy, 60020
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Brescia, Italy, 25123
        • Research Site
      • Candiolo, Italy, 10060
        • Research Site
      • Catania, Italy, 95126
        • Research Site
      • Lecce, Italy, 73100
        • Research Site
      • Lecco, Italy, 23900
        • Research Site
      • Milan, Italy, 20141
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Naples, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Torino, Italy, 10128
        • Research Site
      • Verona, Italy, 37134
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Grzepnica, Poland, 72-003
        • Research Site
      • Lublin, Poland, 20-090
        • Research Site
      • Olsztyn, Poland, 10-561
        • Research Site
      • Poznan, Poland, 60-569
        • Research Site
      • Poznan, Poland, 61-866
        • Research Site
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Research Site
      • Porto, Portugal, 4200-072
        • Research Site
  • Russia
      • Saint Petersburg, Russia, 197758
        • Research Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Research Site
  • South Korea
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 06273
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
      • Seoul, South Korea, 6351
        • Research Site
      • Seoul, South Korea, 01812
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 8907
        • Research Site
      • Barcelona, Spain, ?08041
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Donostia / San Sebastian, Spain, 20014
        • Research Site
      • Granada, Spain, 18014
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28027
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
      • Vigo, Spain, 36312
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Sweden
      • Lund, Sweden, 22185
        • Research Site
  • Taiwan
      • Taipei, Taiwan, 112
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Research Site
      • Istanbul, Turkey (Türkiye), 34093
        • Research Site
      • Şahinbey, Turkey (Türkiye), 27310
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Glasgow, United Kingdom, G12 OYN
        • Research Site
      • Hull, United Kingdom, HU16 5JQ
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Taunton, United Kingdom, TA1 5DA
        • Research Site
  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Research Site
    • Maryland
      • Towson, Maryland, United States, 21204
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Research Site
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site
      • The Bronx, New York, United States, 10461
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Research Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Olaparib
Treatment
Drug: Olaparib
300 mg olaparib (2×150 mg tablets) twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to approximately 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D0817C00098
  • 2019-003777-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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