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Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor BIBF 1120 in Recurrent High-Grade Gliomas

Phase 2
18 Years
Open (Enrolling)
Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma

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Trial Information

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
study treatment).

Inclusion Criteria:

- Histopathologically-confirmed, supratentorial, recurrent glioblastoma; subjects with
an initial diagnosis of a lower grade glioma are eligible if a subsequent biopsy is
determined to be glioblastoma

- Demonstration of recurrent disease on MRI following prior therapy

- Development of progressive disease after having received prior RT, and must have an
interval of at least 12 weeks from the completion of any radiation therapy to study
entry (unless progressive tumor growth is outside the radiation field or there is
histopathological confirmation of recurrent tumor).

- Bi-dimensionally measurable disease (minimum measurement of 1 cm in one dimension) on
MRI performed within 14 days prior to first treatment. (If receiving corticosteroids,
participants must be on a stable or decreasing dose of corticosteroids for at least 5
days prior to baseline MRI.)

- Life expectancy of at least 12 weeks

- KPS >/= 60

- Normal organ and marrow function as defined by protocol

- Recovered from toxic effects of prior therapy

- Sufficient tumor availability (at least 15-20 unstained paraffin slides from any
prior surgery)

Exclusion Criteria:

- Receiving other investigational agent

- More than 2 prior relapses

- Prior therapy with inhibitor of VEGF, VEGFR, PDGFR, or FGFR (including bevacizumab)

- Pregnant or breast-feeding

- Unwilling to agree to adequate contraception, if subject is of child-bearing

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BIBF 1120

- Use of EIAEDs within 14 days of registration

- Evidence of recent hemorrhage on baseline MRI of the brain

- Uncontrolled intercurrent illness

- Uncontrolled hypertension

- History of hypertensive encephalopathy

- History of any of the following within 6 months prior to enrollment: myocardial
infarction or unstable angina, stroke or transient ischemic attack, significant
vascular disease or peripheral arterial thrombosis, abdominal fistula,
gastrointestinal perforation, or intra-abdominal abcess, intracerebral abscess

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks
prior to the first treatment day, or anticipation of need for major surgical
procedure during the course of the study

- Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core
biopsy within 7 days prior to the first treatment day

- Serious non-healing wound, ulcer, or bone fracture

- History of a different malignancy unless disease-free for at least 5 years (unless
cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin)

- HIV positive

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-Month Progression Free Survival

Outcome Description:

To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Patrick Y Wen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

June 2014

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • brain tumor
  • recurrent disease
  • Astrocytoma
  • Glioblastoma
  • Oligodendroglioma
  • Gliosarcoma



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of VirginiaCharlottesville, Virginia  22908
Cleveland ClinicCleveland, Ohio  44195