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By invitation only Phase 3 NCT05303532

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

Phase 3 – large-scale trial before approval
Conditions: Cancer

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
Description
ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab 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.
Who can participate
Inclusion Criteria: The Core Protocol inclusion criteria are: * Provision of signed and dated, written Informed Consent Form (ICF). * Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol. * Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry. There are no additional inclusion criteria for the ROSY-D sub-study. Exclusion Criteria: The Core Protocol exclusion criteria are. * 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 (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological \[example: Response Evaluation Criteria in Solid Tumours\] progression or clinical progression). * Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation. The additional exclusion criteria for the ROSY-D sub-study are: * Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). * Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy. * Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
Interventions
Durvalumab
DRUG
Locations 124
Argentina (1)
Research Site
Rosario
Australia (2)
Research Site
Box Hill
Research Site
Melbourne
Belgium (1)
Research Site
Charleroi
Brazil (2)
Research Site
Barretos
Research Site
São José do Rio Preto
Bulgaria (2)
Research Site
Sofia
Research Site
Sofia
Canada (3)
Research Site
Kingston , Ontario
Research Site
Newmarket , Ontario
Research Site
Toronto , Ontario
China (10)
Research Site
Beijing
Research Site
Changsha
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Hangzhou
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Hangzhou
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Nanjing
Research Site
Shanghai
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Shenyang
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Wenzhou
Research Site
Xi'an
Research Site
Xiamen
Czech Republic (1)
Research Site
Olomouc
France (14)
Research Site
Besançon
Research Site
Bordeaux
Research Site
Brest
Research Site
Dijon
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Lyon
Research Site
Marseille
Research Site
Montpellier
Research Site
Rennes
Research Site
Rouen
Research Site
Saint-Herblain
Research Site
Strasbourg
Research Site
Toulouse
Research Site
Tours
Research Site
Villejuif
Germany (3)
Research Site
Gütersloh
Research Site
Münster
Research Site
Oldenburg
Greece (1)
Research Site
Athens
Hungary (3)
Research Site
Budapest
Research Site
Győr
Research Site
Székesfehérvár
India (1)
Research Site
Chennai
Italy (10)
Research Site
Arezzo
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Bari
Research Site
Catania
Research Site
Meldola
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Milan
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Modena
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Padova
Research Site
Pisa
Research Site
Roma
Research Site
Roma
Japan (8)
Research Site
Bunkyō City
Research Site
Fukuoka
Research Site
Kanazawa
Research Site
Kōtoku
Research Site
Nagoya
Research Site
Okayama
Research Site
Saga
Research Site
Sunto-gun
Malaysia (1)
Research Site
Kuching
Mexico (3)
Research Site
Aguascalientes
Research Site
Mérida
Research Site
Mexico City
Philippines (1)
Research Site
Quezon City
Poland (8)
Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Elblag
Research Site
Lodz
Research Site
Lodz
Research Site
Olsztyn
Research Site
Szczecin
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Warsaw
Romania (1)
Research Site
Suceava
Russia (7)
Research Site
Moscow
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Saint Petersburg
Research Site
Saint Petersburg
South Korea (5)
Research Site
Busan
Research Site
Gwangju
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Spain (7)
Research Site
Barcelona
Research Site
Barcelona
Research Site
Girona
Research Site
Madrid
Research Site
Marbella
Research Site
Santiago de Compostela
Research Site
Valencia
Switzerland (1)
Research Site
Lausanne
Taiwan (5)
Research Site
Taichung
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan District
Thailand (3)
Research Site
Bangkok
Research Site
Chiang Mai
Research Site
Hat Yai
Turkey (6)
Research Site
Ankara
Research Site
Ankara
Research Site
Ankara
Research Site
Bursa
Research Site
Istanbul
Research Site
Izmir
Ukraine (6)
Research Site
Chernivtsi
Research Site
Dnipro
Research Site
Ivano-Frankivsk
Research Site
Kyiv
Research Site
Uzhhorod
Research Site
Vinnytsia
United Kingdom (2)
Research Site
London
Research Site
Sheffield
United States (3)
Research Site
Denver , Colorado
Research Site
Memphis , Tennessee
Research Site
Newport Beach , California
Vietnam (3)
Research Site
Hanoi
Research Site
Hồ Chí Minh
Research Site
Ho Chi Minh City
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
19.04.2022
Completion date
31.12.2026
Registry ID
NCT05303532
Source
clinicaltrials.gov
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