An Open Label, Phase 2 Trial of Orally Administered Bosutinib (SKI-606) in Adult Patients With Recurrent Glioblastoma (GBM)
- Arm A: Participants will receive daily doses of bosutinib orally for 7-9 days prior to
surgery. On the day of the scheduled surgery (either craniotomy or surgical resection as
planned by the treating doctor), participants will take the bosutinib within 6-12 hours of
the surgery. During the surgery, tissue samples of the tumor will be collected to test the
levels of bosutinib in the brain. A contrast-enhanced MRI or CT scan will be done within
days after the surgery. Daily dosing of bosutinib will resume after a recovery period of 10
days. From then on, the study will be divided into 28-day cycles.
The following tests/procedures will be performed regularly during cycles of study treatment:
medical history; physical exam; blood tests; contrast-enhanced CT or MRI scans (even
numbered cycles only).
- Arm B: Participants will receive daily doses of bosutinib. The study is divided int
28-day cycles. There are no breaks from taking bosutinib between treatment cycles. The
following tests/procedures will be performed regularly during cycles of study
treatment: medical history; physical exam; blood tests; contrast-enhanced CT or MRI
scans (even numbered cycles only).
- Participants may continue to receive daily bosutinib until their disease worsens, they
experience unmanageable side-effects, or they decide to stop treatment.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess progression-free survival at six months in patients with recurrent GBM at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B)
Tracy Batchelor, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana=Farber Cancer Institute||Boston, Massachusetts 02115|