Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma

Phase 2 Completed NCT01339052

Condition	Glioblastoma
Phase	Phase 2
Sponsor	L. Nicolas Gonzalez Castro, MD, PhD
Status	Completed
Enrollment	65 participants
Interventions	BKM120, Surgery
Start date	Sep, 2011
Completion date	Oct, 2016
Results posted	Jun 14, 2017

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.

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

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma — Wake Forest University Health Sciences
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblast — National Cancer Institute (NCI)
TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma — National Cancer Institute (NCI)
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant G — City of Hope Medical Center
A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care — Bryan Allen
Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed M — National Cancer Institute (NCI)

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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