Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
2期
已完成
NCT01339052
| 适应症 | Glioblastoma |
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| 分期 | 2期 |
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| 申办方 | L. Nicolas Gonzalez Castro, MD, PhD |
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| 状态 | 已完成 |
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| 受试者人数 | 65 人 |
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| 干预(药物) | BKM120, Surgery |
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| 开始日期 | 2011年9月 |
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| 完成日期 | 2016年10月 |
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| 结果公布日 | 2017年6月14日 |
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摘要
BKM120 is a newly discovered drug that has been used in other research studies. Information from those other research studies suggests that BKM120 may help to slow or stop the growth of malignant gliomas. The purpose of this study is to see how well BKM120 works in patients with malignant gliomas. Patients on this study will be treated in two groups: patients who are going to receive surgery and those who will not receive surgery. This study is trying to determine how effective BKM120 is in stopping cancer cells from growing. For patients receiving surgery the research will also try to determine if an effective level of BKM120 can penetrate the brain before surgery.
Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]
Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment. · Participants
| Cohort 1: Surgical Subjects | 6 Participants |
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| Cohort 1: Surgical Subjects | 1 Participants |
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| Cohort 1: Surgical Subjects | 7 Participants |
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| Cohort 1: Surgical Subjects | 1 Participants |
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6-Month Progression-Free Survival (PFS6) [Cohort 2]
Participants were assessed radiologically every other cycle on treatment; Relevant for this outcome is up to month 6 evaluation. · proportion of participants
| Cohort 2: Non-surgical Subjects | 0.08 proportion of participants |
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BKM120 Brain-to-Plasma Ratio at Time of Surgery [Cohort 1]
Samples were collected at surgery (surgical tumor specimen and plasma sample) which occurred after up to 12 days of BKM120 treatment. · ratio tumor-to-plasma
| Cohort 1: Surgical Subjects | 1.00 ratio tumor-to-plasma |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。