NCT05629234进行中（未招募）3 期
ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 28
- 主要终点
- Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
研究概览
简要总结
The rationale of the ROSY-T study is to continue to provide study treatment for patients who have participated in a parent study with osimertinib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
详细描述
ROSY-T is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using osimertinib 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, until they meet one of the treatment discontinuation criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written Informed Consent Form (ICF).
- •Patient is currently deriving clinical benefit from continued treatment with osimertinib in an AstraZeneca parent study using osimertinib monotherapy which has met its endpoints or has otherwise stopped.
- •Patients should be using adequate contraceptive measures.
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 is permitted by local regulation.
- •Exclusion Criteria for the sub-study:
- •1. Active infection including active hepatitis C and Human immunodeficiency virus (HIV) infection or active uncontrolled Hepatitis B virus (HBV) infection. Screening for chronic conditions is not required.
- •Patients with HBV infection are only eligible if they meet all the following criteria:
- •Demonstrated absence of HCV co-infection or history of HCV co-infection;
- •Demonstrated absence of HIV infection;
- •Patients receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to < 100 IU/mL, and transaminase levels are below ULN.
- •Patients with a resolved or chronic HBV infection are eligible if they are:
- •Negative for HBsAg and positive for anti-HBc IgG. In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment; or
- •Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below < 100 IU/mL (ie, patients are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment.
- •Should participants with HIV infection be included, patients are only eligible if they meet all the following criteria:
- •Undetectable viral RNA load for 6 months
- •CD4+ count of > 350 cells/μL
- •No history of AIDS-defining opportunistic infection within the past 12 months (to be determined by hepatologist) post treatment
- •Stable for at least 4 weeks on anti-HIV medications.
研究组 & 干预措施
Osimertinib
Experimental
Participants will receive Osimertinib
干预措施: Osimertinib (Drug)
结局指标
主要结局
Number of patients with Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
时间窗: Until 90 days after the last dose of study treatment
Safety and tolerability of osimertinib will be assessed.
次要结局
未报告次要终点
研究者
研究点 (28)
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