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

February 23, 2024 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

Enrolling by invitation

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

292

Phase

  • 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
      • Namur, Belgium, 5000
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Plovdiv, Bulgaria, 4004
        • 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
      • Quebec City, Quebec, Canada, G1S 4L8
        • Research Site
  • China
      • Changchun, China, 130021
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Shanghai, China, 200032
        • 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
      • Praha 2, Czechia, 128 08
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
  • Finland
      • Kuopio, Finland, 70210
        • Research Site
  • France
      • Lille Cedex, France, 59020
        • Research Site
      • Lyon, France, 69373
        • Research Site
      • Plerin, 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
      • Milan, Italy, 20141
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Padova, Italy, 35128
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Torino, Italy, 10128
        • Research Site
      • Verona, Italy, 37134
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06273
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Seoul, Korea, Republic of, 6351
        • Research Site
      • Seoul, Korea, Republic of, 01812
        • Research Site
  • Poland
      • Białystok, 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, 61-866
        • Research Site
      • Poznań, Poland, 60-569
        • Research Site
  • Portugal
      • Porto, Portugal, 4200-072
        • Research Site
  • Russian Federation
      • Sankt-Peterburg, Russian Federation, 197758
        • Research Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 8907
        • Research Site
      • Barcelona, Spain, ?08041
        • Research Site
      • Cordoba, Spain, 14004
        • 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
      • Ankara, Turkey, 06230
        • Research Site
      • Istanbul, Turkey, 34093
        • Research Site
      • Sahinbey, Turkey, 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
    • California
      • West Hollywood, California, United States, 90048
        • Research Site
    • 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
      • Bronx, New York, United States, 10461
        • Research Site
      • New York, New York, United States, 10032
        • 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

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
Intervention / Treatment
Experimental: Olaparib
Treatment
Drug: Olaparib
300 mg olaparib (2×150 mg tablets) twice daily

What is the study measuring?

Primary Outcome Measures

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

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)

August 4, 2020

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Breast Cancer

Clinical Trials on Olaparib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe