EUCTR2016-005189-75-HU进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER EXTENSION AND LONG-TERM OBSERVATIONAL STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH- AND/OR F. HOFFMANN LA ROCHE LTD-SPONSORED ATEZOLIZUMAB STUDY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 556
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- •- Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or
- •Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study
- •- First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- •- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- •- Able to comply with the extension study, in the investigator's judgment
- •- Will comply with contraception criteria detailed in BO39633 protocol
- •- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
- •2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study and continue safety and survival follow-up only in the extension study:
- •- Discontinuation of atezolizumab-based therapy in parent study and in survival follow up at the time of parent study closure
- •- Eligible for continuing or crossing over to atezolizumab-based therapy as per the parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the parent-study closure.
- •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 278
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 278
排除标准
- •1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- •- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- •- Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient
- •- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (+/- 7 days) allowed in the parent study.
- •- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- •- Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study (if applicable)
- •- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
- •- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade <= 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- •- Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the patient at high risk for treatment-related complications
- •- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- •- Pregnant or lactating, or intending to become pregnant during the extension study
- •2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available Tecentriq®outside this extension study and continue safety and survival follow-up only in the extension study:
- •- Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure
研究者
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