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 - ROSY-D

AstraZeneca AB0 个研究点目标入组 175 人开始时间: 2023年1月16日最近更新: 2024年1月8日

研究概览

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•1. Provision of signed and dated, written ICF.
•2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AZ 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 103
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 72

•Core Protocol exclusion criteria:
•1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
•2. Currently receiving treatment with any prohibited medication(s).
•3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
•4. Permanent discontinuation from the parent study due to toxicity or disease progression.
•5. Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
•Additional exclusion criteria for the ROSY-D sub-study:
•6. Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies).
•7. 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.
•8. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of

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