Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma
2상
완료
NCT01339052
| 대상 질환 | Glioblastoma |
|---|
| 임상 단계 | 2상 |
|---|
| 스폰서 | L. Nicolas Gonzalez Castro, MD, PhD |
|---|
| 상태 | 완료 |
|---|
| 참여자 수 | 65 명 |
|---|
| 중재(약물) | BKM120, Surgery |
|---|
| 시작일 | 2011년 9월 |
|---|
| 완료일 | 2016년 10월 |
|---|
| 결과 공개일 | 2017년 6월 14일 |
|---|
요약
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 |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
같은 질환의 다른 임상
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.