BENITIONSClinical Trial Intelligence

Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma

Фаза 2 Завершено NCT01339052

ЗаболеваниеGlioblastoma
ФазаФаза 2
СпонсорL. Nicolas Gonzalez Castro, MD, PhD
СтатусЗавершено
Участники65 участн.
ВмешательствоBKM120, Surgery
Дата начала09.2011
Дата завершения10.2016
Публикация результатов14.06.2017

Кратко

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 Subjects6 Participants
Cohort 1: Surgical Subjects1 Participants
Cohort 1: Surgical Subjects7 Participants
Cohort 1: Surgical Subjects1 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 Subjects0.08 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 Subjects1.00 ratio tumor-to-plasma

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