CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
BKM120 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01339052
NCT01339052Phase 2Completed
CompareCT.gov

A Phase II Study of BKM 120 for Patients With Recurrent Glioblastoma and Activated PI3K Pathway

Patrick Y. Wen, MD·interventional·Posted Apr 20, 2011·Updated Mar 19, 2019

In Brief

A Phase 2 clinical trial evaluating BKM120 and Surgery for Glioblastoma. Completed, enrolled 65 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited States
CollaboratorsBrigham and Women's Hospital, Massachusetts General Hospital, Novartis Pharmaceuticals, M.D. Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, University of California, San Francisco, University of California, Los Angeles, University of Utah

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2016
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.2 years ago

Interventions

BKM120drug

Surgeryprocedure

Surgery