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.
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
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.
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There are 110 Locations for this study
West Hollywood California, 90048, United States
Boca Raton Florida, 33486, United States
Towson Maryland, 21204, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55407, United States
Basking Ridge New Jersey, 07920, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10461, United States
New York New York, 10032, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15224, United States
Willow Grove Pennsylvania, 19090, United States
Providence Rhode Island, 02905, United States
Germantown Tennessee, 38138, United States
Houston Texas, 77030, United States
Leuven , 3000, Belgium
Namur , 5000, Belgium
Rio de Janeiro , 22793, Brazil
Plovdiv , 4000, Bulgaria
Plovdiv , 4004, Bulgaria
Halifax Nova Scotia, B3H 1, Canada
Kingston Ontario, K7L 2, Canada
Mississauga Ontario, L5M 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A-3, Canada
Quebec City Quebec, G1S 4, Canada
Changchun , 13002, China
Hangzhou , 31002, China
Shanghai , 20003, China
Brno , 625 0, Czechia
Brno , 656 5, Czechia
Olomouc , 779 0, Czechia
Ostrava Poruba , 708 5, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , 150 0, Czechia
Aalborg , 9000, Denmark
Kuopio , 70210, Finland
Lille Cedex , 59020, France
Lyon , 69373, France
Plerin , 22190, France
Villejuif , 94800, France
Dresden , 1307, Germany
Budapest , 1032, Hungary
Budapest , 1122, Hungary
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Ancona , 60020, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Candiolo , 10060, Italy
Catania , 95126, Italy
Lecce , 73100, Italy
Lecco , 23900, Italy
Milano , 20132, Italy
Milan , 20141, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Roma , 00168, Italy
Torino , 10128, Italy
Verona , 37134, Italy
Seoul , 01812, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 6351, Korea, Republic of
Białystok , 15-02, Poland
Grzepnica , 72-00, Poland
Lublin , 20-09, Poland
Olsztyn , 10-56, Poland
Poznan , 61-86, Poland
Poznań , 60-56, Poland
Porto , 4200-, Portugal
Sankt-Peterburg , 19775, Russian Federation
Ljubljana , 1000, Slovenia
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 8907, Spain
Barcelona , ?0804, Spain
Cordoba , 14004, Spain
Granada , 18014, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Pamplona , 31008, Spain
San Sebastian , 20014, Spain
Valencia , 46026, Spain
Vigo , 36312, Spain
Zaragoza , 50009, Spain
Lund , 22185, Sweden
Taipei , 112, Taiwan
Ankara , 06230, Turkey
Istanbul , 34093, Turkey
Sahinbey , 27310, Turkey
Birmingham , B18 7, United Kingdom
Edinburgh , EH4 2, United Kingdom
Glasgow , G12 O, United Kingdom
Hull , HU16 , United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Taunton , TA1 5, United Kingdom
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