EUCTR2016-005189-75-SI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
- 385
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
- •Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who
- •roll over from IMpower133):
- •- 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, with no access to commercially available comparator
- •- 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 from the IMpower133 parent study only
- •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
- •- Discontinuation of atezolizumab-based therapy in the IMpower133
- •parent study and in survival follow up at the time of the IMpower133
- •parent study closure
- •- Eligible for continuing or crossing over to atezolizumab-based
- •therapy as per the IMpower133 parent protocol and have access to
- •commercially available atezolizumab (Tecentriq®) outside this extension
- •study at the time of the IMpower133 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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •Patients who continue treatment as well as safety 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
- •- 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
研究者
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