NCT05303532Enrolling By Invitation3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- AstraZeneca
- 入组人数
- 214
- 试验地点
- 123
- 主要终点
- Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
研究概览
简要总结
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.
详细描述
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.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Durvalumab
Experimental
Participants will receive durvalumab.
干预措施: Durvalumab (Drug)
结局指标
主要结局
Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: From baseline up to follow up at 90 days after the last dose of study drug.
To monitor safety and tolerability of continuous study treatment to patients who continue to benefit at the end of the clinical trial by measuring the primary outcome of Serious Adverse Events (SAEs).
次要结局
未报告次要终点
研究者
研究点 (123)
Loading locations...
相似试验
进行中（未招募）
3 期
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)CancerNCT05629234AstraZeneca37
进行中（未招募）
3 期
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With OlaparibOvarian CancerBreast CancerNCT04421963AstraZeneca185
招募中
1 期
Roll Over Study for Patients Who Have Completed a Previous OncologyStudy with DurvalumabPost-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract.First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC).Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumor pathology.Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)Various types of cancer ( dependent on parent study)MedDRA version: 21.1Level: PTClassification code 10061272Term: Malignant urinary tract neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-003031-29-ESAstraZeneca AB175
尚未招募
3 期
Roll Over StudY for Patients Who Have Completed & Benefitted from a Previous Oncology Study With Durvalumab (ROSY-D)CTRI/2024/01/061411AstraZeneca AB
已完成
2 期
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating ElotuzumabMultiple MyelomaNCT02719613Bristol-Myers Squibb67