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 - NI

AstraZeneca AB0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: AstraZeneca AB

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•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 studys protocol.
•There are no additional inclusion criteria for the ROSY-D sub-study

排除标准

•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 as permitted by local or 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 by 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 less than or equal to 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment or study regimen, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

研究者

发起方

AstraZeneca AB

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