Clinical Trial Details
Braintumor Website

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NCT01349660 : Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

Phase I ONLY:

- Advanced, metastatic solid tumor that has progressed after standard therapy, or is a
tumor type resistant to therapy, and for which bevacizumab is clinically appropriate.

- Patient may have measurable disease or non-measureable disease as defined by RECIST
v1.1 criteria

Phase II ONLY:

- Progressive GBM after treatment with surgical resection (if possible) and 1st line

- No previous treatment with a PI3K inhibitor. Previous treatment with bevacizumab as a
component of first-line therapy is allowed.

- At least one measurable or evaluable lesion definable by MRI scan. Disease must be
measurable by RANO criteria.

- Archival tumor tissue available for correlative testing.


- Patient must be ? 4 weeks from administration of last dose of cancer therapy
(including radiation therapy, biologic therapy, hormonal therapy, or chemotherapy).
Patients who receive a small molecule targeted therapy as part of their first line
treatment regimen must be ? 4 weeks or ? 5 half lives from administration of last
dose, whichever is shorter. The patient must have recovered from or come to a new
chronic or stable baseline from all treatment-related toxicities.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- Life expectancy of ? 3 months.

- Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

- Patients with diarrhea ? grade 2.

- Patients with uncontrolled type I or type II diabetes mellitus, defined as a fasting
plasma glucose ?120 mg/dL.

- Patients who have received prior treatment with a P13K inhibitor.

- Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose
of 1 mg allowed for port line patency permitted).

- Patient has active cardiac disease including any of the following:

- Left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Grated
acquisition (MUGA) scan or echocardiogram (ECHO)

- QTc > 480 msec on screening ECG (using the QTcF formula)

- Angina pectoris that requires the use of anti-anginal medication

- Ventricular arrhythmias except for benign premature ventricular contractions

- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled
with medication

- Conduction abnormality requiring a pacemaker

- Valvular disease with documented compromise in cardiac function

- Symptomatic pericarditis

- Patients who are currently receiving treatment with medication with a known risk to
prolong the QT interval or inducing Torsades de Pointes and the treatment cannot
either be discontinued or switched to a different medication prior to starting study

- Patients with clinical history of hemoptysis or hematemesis (defined as having bright
red blood of ½ teaspoon or more per episode) ?1 month prior to study enrollment.

- Patients with any history of a bleeding diathesis or coagulopathy (in the absence of
therapeutic anticoagulation)

- Patients who have received chemotherapy or targeted anticancer therapy ? 4 weeks (6
weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must
recover to a grade 1 before starting the trial.

- Patients who have received any continuous or intermittent small molecule therapeutics
(excluding monoclonal antibodies) ? 5 effective half lives prior to starting study
drug or who have not recovered from side effects of such therapy.

- Patients who have been treated with any hematopoietic colony-stimulating factors
(e.g. G-CSF, GM-CSF) ? 2 weeks prior to starting study drug. Erythropoietin or
darbepoetin therapy, if initiated at least 2 weeks prior to enrollment may be

- Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal
shunt or significant traumatic injury ? 28 days prior to entry.
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