Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
第2相
完了
NCT01339052
| 対象疾患 | Glioblastoma |
|---|
| 相 | 第2相 |
|---|
| スポンサー | L. Nicolas Gonzalez Castro, MD, PhD |
|---|
| ステータス | 完了 |
|---|
| 参加者数 | 65 名 |
|---|
| 介入(薬剤) | BKM120, Surgery |
|---|
| 開始日 | 2011年9月 |
|---|
| 完了日 | 2016年10月 |
|---|
| 結果公開日 | 2017年6月14日 |
|---|
概要
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 |
|---|
| Cohort 1: Surgical Subjects | 1 Participants |
|---|
| Cohort 1: Surgical Subjects | 7 Participants |
|---|
| Cohort 1: Surgical Subjects | 1 Participants |
|---|
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 |
|---|
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 |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
同じ疾患の他の治験
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。