Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

153

Study ID:

NCT04421963

Recruitment Status:

Enrolling by invitation

Sponsor:

AstraZeneca

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There are 102 Locations for this study

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Research Site
Boca Raton Florida, 33486, United States
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Towson Maryland, 21204, United States
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Detroit Michigan, 48201, United States
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Minneapolis Minnesota, 55407, United States
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Basking Ridge New Jersey, 07920, United States
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Hackensack New Jersey, 07601, United States
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Bronx New York, 10461, United States
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New York New York, 10032, United States
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Philadelphia Pennsylvania, 19104, United States
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Pittsburgh Pennsylvania, 15224, United States
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Willow Grove Pennsylvania, 19090, United States
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Providence Rhode Island, 02905, United States
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Germantown Tennessee, 38138, United States
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Houston Texas, 77030, United States
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Leuven , 3000, Belgium
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Namur , 5000, Belgium
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Rio de Janeiro , 22793, Brazil
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Plovdiv , 4000, Bulgaria
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Plovdiv , 4004, Bulgaria
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Sofia , 1330, Bulgaria
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Halifax Nova Scotia, B3H 1, Canada
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Kingston Ontario, K7L 2, Canada
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Mississauga Ontario, L5M 2, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H2X 0, Canada
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Montreal Quebec, H3T 1, Canada
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Montreal Quebec, H4A-3, Canada
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Quebec City Quebec, G1S 4, Canada
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Changchun , 13002, China
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Shanghai , 20003, China
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Brno , 625 0, Czechia
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Brno , 656 5, Czechia
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Olomouc , 779 0, Czechia
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Ostrava Poruba , 708 5, Czechia
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Praha 2 , 128 0, Czechia
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Praha 5 , 150 0, Czechia
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Aalborg , 9000, Denmark
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Kuopio , 70210, Finland
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Lille Cedex , 59020, France
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Lyon , 69373, France
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Plerin , 22190, France
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Villejuif , 94800, France
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Dresden , 1307, Germany
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Budapest , 1032, Hungary
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Budapest , 1122, Hungary
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Haifa , 31096, Israel
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Jerusalem , , Israel
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Petah Tikva , 49100, Israel
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Ramat Gan , 52656, Israel
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Tel Aviv , 64239, Israel
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Ancona , 60020, Italy
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Bologna , 40138, Italy
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Brescia , 25123, Italy
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Candiolo , 10060, Italy
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Catania , 95126, Italy
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Lecce , 73100, Italy
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Milano , 20132, Italy
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Roma , 00168, Italy
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Torino , 10128, Italy
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Verona , 37134, Italy
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lJongno-gu , 03080, Korea, Republic of
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Seoul , 01812, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 6351, Korea, Republic of
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Białystok , 15-02, Poland
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Grzepnica , 72-00, Poland
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Lublin , 20-09, Poland
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Olsztyn , 10-56, Poland
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Poznan , 61-86, Poland
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Poznań , 60-56, Poland
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Porto , 4200-, Portugal
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Sankt-Peterburg , 19775, Russian Federation
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Ljubljana , 1000, Slovenia
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Badalona , 08916, Spain
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Barcelona , 08035, Spain
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Barcelona , 8907, Spain
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Barcelona , ?0804, Spain
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Cordoba , 14004, Spain
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Granada , 18014, Spain
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Madrid , 28027, Spain
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Madrid , 28041, Spain
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Madrid , 28046, Spain
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Pamplona , 31008, Spain
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Valencia , 46026, Spain
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Vigo , 36312, Spain
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Zaragoza , 50009, Spain
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Lund , 22185, Sweden
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Ankara , 06230, Turkey
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Istanbul , 34093, Turkey
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Edinburgh , EH4 2, United Kingdom
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Glasgow , G12 O, United Kingdom
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Hull , HU16 , United Kingdom
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London , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Taunton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

153

Study ID:

NCT04421963

Recruitment Status:

Enrolling by invitation

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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