CompletedPhase 2

Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma

United States65 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must be able to understand and be willing to sign a written informed consent document. * Subjects must be able to adhere to the dosing and visit schedules, and agree to record medication times accurately and consistently in a daily diary. * Participants must be at least 18 years old. * Participants must have a Karnofsky performance status (KPS) ≥ 60. Nature of illness and treatment history * Participants must have histologically confirmed glioblastoma or variants. Participants will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of glioblastoma or variants is made. * Participants may have had treatment for no more than 1 prior relapse(NOTE: Relapse is defined as progression following initial therapy (i.e., radiation ± chemotherapy)). The intent therefore is that patients had no more than 2 prior therapies (initial and treatment for 1 relapse). If the participant had a surgical resection for relapsed disease and no antitumor therapy was instituted for up to 12 weeks, and the participant undergoes another surgical resection, this is considered as a second relapse. For participants who had prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma will be considered the first relapse). * Participants must have shown unequivocal evidence for tumor progression by MRI or CT scan. * For Cohort 2, CT or MRI within 14 days prior to start of study drug. MRIs should include va…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]

Timeframe: Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.

6-Month Progression-Free Survival (PFS6) [Cohort 2]

Timeframe: Participants were assessed radiologically every other cycle on treatment; Relevant for this outcome is up to month 6 evaluation.

BKM120 Brain-to-Plasma Ratio at Time of Surgery [Cohort 1]

Timeframe: Samples were collected at surgery (surgical tumor specimen and plasma sample) which occurred after up to 12 days of BKM120 treatment.

BKM120 Tumor Tissue Concentration at Time of Surgery [Cohort 1]

Timeframe: Samples were collected at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.

BKM120 Plasma Concentration at Time of Surgery [Cohort 1]

Timeframe: Samples were collected at surgery which occurred after up to 12 days of BKM120 treatment.

Trial details

NCT IDNCT01339052

SponsorL. Nicolas Gonzalez Castro, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

Results submitted2017-03-14

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