Phase I/II Study of the Combination of BKM120 and Bevacizumab in Patients With Refractory Solid Tumors (Phase I) and Relapsed/Refractory Glioblastoma Multiforme (Phase II)
This is an open-label, non-randomized Phase I study of patients with advanced refractory
solid tumors followed by a Phase II study for the second-line treatment of patients with
relapsed/refractory glioblastoma multiforme.
The phase I study will determine the MTD of BKM120 when combined with bevacizumab. The
Phase I portion will follow a standard dose escalation design, beginning with dose level 1.
The sequence of dose escalation for BKM120 and bevacizumab is based on a starting dose of 60
mg/day for BKM120 (i.e. 50% of the MTD of BKM120 when administered as a single agent). A
maximum of three BKM120 dose levels will be evaluated. Bevacizumab will be fixed at 10
mg/kg IV and will be administered every two weeks. Approximately 18 patients will be
enrolled during the Phase I portion to establish the MTD.
In the Phase II portion of this study, patients with relapsed/refractory GBM following first
line therapy will receive treatment with the BKM120/bevacizumab combination. Limited BKM120
pharmacokinetic evaluation will be performed on all patients treated during the Phase II
portion of the study. Patients will be reevaluated for response to treatment after 2 cycles
(8 weeks). Patients with objective response or stable disease will continue treatment, with
subsequent reevaluations every 8 weeks, until disease progression or unacceptable toxicity
occurs.
Two populations of patients with relapsed/refractory GBM will be treated in the Phase II
trial: 1) patients with no previous exposure to bevacizumab (N= 55) and 2) patients who
received bevacizumab as part of first-line combined modality treatment (N= 20).
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish the optimal dose of BKM120 that can be administered in combination with a standard dose of bevacizumab. (Phase I)
18 months
No
John Hainsworth, MD
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI CNS 13
NCT01349660
December 2011
August 2014
Name | Location |
---|---|
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
St. Louis Cancer Care | Chesterfield, Missouri 63017 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Yale School of Medicine | New Haven, Connecticut 06510 |
Woodlands Medical Specialists | Pensacola, Florida 32503 |