Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

Breast Cancer Clinical Trial

— ROSY-O  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04421963
• Other study ID #: D0817C00098
• Secondary ID: 2019-003777-26
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 4, 2020
• Est. completion date: December 10, 2024

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 292
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer

Intervention

Drug:
• Olaparib
300 mg olaparib (2×150 mg tablets) twice daily

Locations

Country	Name	City	State
Belgium	Research Site	Leuven
Belgium	Research Site	Namur
Brazil	Research Site	Rio de Janeiro
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec City	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
China	Research Site	Changchun
China	Research Site	Hangzhou
China	Research Site	Shanghai
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Olomouc
Czechia	Research Site	Ostrava Poruba
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 5
Denmark	Research Site	Aalborg
Finland	Research Site	Kuopio
France	Research Site	Lille Cedex
France	Research Site	Lyon
France	Research Site	Plerin
France	Research Site	Villejuif
Germany	Research Site	Dresden
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Petah Tikva
Israel	Research Site	Ramat Gan
Israel	Research Site	Tel Aviv
Italy	Research Site	Ancona
Italy	Research Site	Bologna
Italy	Research Site	Brescia
Italy	Research Site	Candiolo
Italy	Research Site	Catania
Italy	Research Site	Lecce
Italy	Research Site	Milan
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Roma
Italy	Research Site	Torino
Italy	Research Site	Verona
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Poland	Research Site	Bialystok
Poland	Research Site	Grzepnica
Poland	Research Site	Lublin
Poland	Research Site	Olsztyn
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Portugal	Research Site	Porto
Russian Federation	Research Site	Sankt-Peterburg
Slovenia	Research Site	Ljubljana
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Cordoba
Spain	Research Site	Granada
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Pamplona
Spain	Research Site	Valencia
Spain	Research Site	Vigo
Spain	Research Site	Zaragoza
Sweden	Research Site	Lund
Taiwan	Research Site	Taipei
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Sahinbey
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Taunton
United States	Research Site	Basking Ridge	New Jersey
United States	Research Site	Boca Raton	Florida
United States	Research Site	Bronx	New York
United States	Research Site	Detroit	Michigan
United States	Research Site	Germantown	Tennessee
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Houston	Texas
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	New York	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Providence	Rhode Island
United States	Research Site	Towson	Maryland
United States	Research Site	West Hollywood	California
United States	Research Site	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Slovenia,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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