A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
1/2期
进行中(已停止招募)
NCT02734004
| 适应症 | Ovarian, Breast, SCLC, Gastric Cancers |
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| 分期 | 1/2期 |
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| 申办方 | AstraZeneca |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 264 人 |
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| 干预(药物) | Olaparib, MEDI4736, Bevacizumab |
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| 开始日期 | 2016年3月17日 |
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| 完成日期 | 2021年9月17日 |
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| 结果公布日 | 2023年10月13日 |
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摘要
The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.
Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019. · percentage of participants
| Initial Stage: Small Cell Lung Cancer | 28.9 percentage of participants |
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| Initial Stage: Breast Cancer | 80.0 percentage of participants |
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| Initial Stage: Ovarian Cancer | 81.3 percentage of participants |
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| Initial Stage: Gastric Cancer | 25.6 percentage of participants |
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Second Stage Cohort: Objective Response Rate (ORR)
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021. · percentage of participants
| Second Stage: Ovarian Cancer Expansion | 92.2 percentage of participants |
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Second Stage Cohorts: DCR at Week 24
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021. · percentage of participants
| Second Stage: Ovarian Cancer Triplet | 74.2 percentage of participants |
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| Second Stage: Ovarian Cancer Doublet | 28.1 percentage of participants |
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