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

Официальное название

ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Durvalumab
  Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.

Первичные конечные точки

• Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Срок оценки: From baseline up to follow up at 90 days after the last dose of study drug.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 14 центров

• Research Site — Besançon
• Research Site — Bordeaux
• Research Site — Brest
• Research Site — Dijon
• Research Site — Lyon
• Research Site — Marseille
• Research Site — Montpellier
• Research Site — Rennes
• … и ещё 6 центров

Китай · 10 центров

• Research Site — Пекин
• Research Site — Чанша
• Research Site — Ханчжоу
• Research Site — Ханчжоу
• Research Site — Нанкин
• Research Site — Шанхай
• Research Site — Шэньян
• Research Site — Wenzhou
• … и ещё 2 центра

Италия · 10 центров

• Research Site — Arezzo
• Research Site — Bari
• Research Site — Catania
• Research Site — Meldola
• Research Site — Milan
• Research Site — Modena
• Research Site — Padova
• Research Site — Pisa
• … и ещё 2 центра

Япония · 8 центров

• 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

Польша · 8 центров

• Research Site — Bialystok
• Research Site — Bydgoszcz
• Research Site — Elblag
• Research Site — Lodz
• Research Site — Lodz
• Research Site — Olsztyn
• Research Site — Szczecin
• Research Site — Warsaw

Россия · 7 центров

• Research Site — Moscow
• Research Site — Moscow
• … и ещё 5 центров

Испания · 7 центров

Список центров уточняется — проверьте первичный протокол.

Turkey (Türkiye) · 6 центров

Список центров уточняется — проверьте первичный протокол.

Украина · 6 центров

Список центров уточняется — проверьте первичный протокол.

South Korea · 5 центров

Список центров уточняется — проверьте первичный протокол.

Тайвань · 5 центров

Список центров уточняется — проверьте первичный протокол.

США · 3 центра

• Research Site — Newport Beach
• Research Site — Denver
• Research Site — Memphis

Канада · 3 центра

• Research Site — Kingston
• Research Site — Newmarket
• Research Site — Toronto

Германия · 3 центра

• Research Site — Gütersloh
• Research Site — Münster
• Research Site — Oldenburg

Венгрия · 3 центра

• Research Site — Budapest
• Research Site — Győr
• Research Site — Székesfehérvár

Таиланд · 3 центра

Список центров уточняется — проверьте первичный протокол.

Вьетнам · 3 центра

Список центров уточняется — проверьте первичный протокол.

Австралия · 2 центра

• Research Site — Box Hill
• Research Site — Melbourne

Бразилия · 2 центра

• Research Site — Barretos
• Research Site — São José do Rio Preto

Болгария · 2 центра

• Research Site — Sofia
• Research Site — Sofia

Мексика · 2 центра

• Research Site — Mexico City
• Research Site — Mérida

Великобритания · 2 центра

Список центров уточняется — проверьте первичный протокол.

Аргентина · 1 центр

• Research Site — Rosario

Бельгия · 1 центр

• Research Site — Charleroi

Чехия · 1 центр

• Research Site — Olomouc

Греция · 1 центр

• Research Site — Athens

Индия · 1 центр

• Research Site — Chennai

Малайзия · 1 центр

• Research Site — Kuching

Филиппины · 1 центр

• Research Site — Quezon City

Румыния · 1 центр

• Research Site — Suceava

Швейцария · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05303532 · D4191C00137 · 2021-003031-29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗