Clinical Trial Details
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NCT01380782 : BIBF 1120 for Recurrent High-Grade Gliomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histopathologically-confirmed, supratentorial, recurrent high-grade glioma
(glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma or
anaplastic oligoastrocytoma); subjects with an initial diagnosis of a lower grade
glioma are eligible if a subsequent biopsy is determined to be high-grade glioma

- 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
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