Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor BIBF 1120 in Recurrent High-Grade Gliomas
This is a two arm, multicenter, open label phase II trial in adult patients with recurrent
supratentorial high-grade glioma. One arm (the "bevacizumab naïve" arm) will enroll patients
who have not received prior bevacizumab therapy, and the other arm (the "post-bevacizumab"
arm) will enroll patients who have experienced progression on bevacizumab.
All subjects will receive BIBF 1120 at 200mg orally, twice daily in cycles of 28 days.
Subjects will come to the clinic on Day 1 of each cycle (or within 2 days prior) for blood
and urine tests and a physical and neurologic exam. Bloods will also be checked within 2
days before or after Day 15 of Cycles 1 and 2. An additional blood sample will be taken on
Days 1 and 8 of Cycle 1, at the start of every even-numbered cycle, and at the end of active
study treatment. Subjects will have gadolinium-enhanced brain MRI scans performed with
tumor measurements at screening, at the start of even-numbered cycles, and at the end of
active study treatment(unless already obtained within 4 weeks of completing study
treatment). 40 study subjects will have diffusion- and perfusion-weighted MRI at baseline,
after 1 week on therapy (± 2 days), within 2 days prior to the start of every even-numbered
cycle, and at the end of treatment (unless already obtained within 4 weeks of completing
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
6-Month Progression Free Survival
To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).
Patrick Y Wen, M.D.
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of Virginia||Charlottesville, Virginia 22908|
|Cleveland Clinic||Cleveland, Ohio 44195|