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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- To provide continuous study treatment to patients
研究概览
简要总结
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
The rationale of the ROSY study is to provide continuous study treatment for patients who are continuing to derive clinical benefit from treatment at the end of a clinical trial, as judged by the Investigator, while monitoring safety and tolerability. Patients will be enrolled into the appropriate ROSY study based upon the treatment received in their parent study.
The duration of clinical benefit from study treatment for an individual patient can exceed the duration of a clinical trial. To ensure continued supply of treatment to a patient who, as judged by the Investigator, is still receiving benefit when he/she either completes the parent study or when the parent study closes, a roll-over study is the most universally acceptable mechanism for continuing to provide ongoing study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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).
- •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.
结局指标
主要结局
To provide continuous study treatment to patients
时间窗: SAEs reported until 90 days after the last dose of | study treatment
who continue to benefit at the end of a clinical study,
时间窗: SAEs reported until 90 days after the last dose of | study treatment
while monitoring safety and tolerability
时间窗: SAEs reported until 90 days after the last dose of | study treatment
次要结局
未报告次要终点