Clinical Trial Details
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NCT01112527 : PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 18 years of age or older

- Histologically confirmed diagnosis of a recurrent primary WHO grade IV malignant
glioma (glioblastoma). Patients with recurrent disease whose diagnostic pathology
confirmed glioblastoma will not need re-biopsy. Patients with prior low-grade glioma
or anaplastic glioma are eligible if histologic assessment demonstrates
transformation to GBM.

- Evidence of EGFR gene amplification by fluorescence in situ hybridization (FISH) in
archival tumor material.

- Patients must have at least 15 unstained slides or 1 tissue block (frozen or paraffin
embedded) available from a prior biopsy or surgery.

- For Arm A: patients must be at first recurrence of GBM, must not have had previous
anti-VEGF therapy, and must be candidates for surgical partial or gross-total

- For Arm B: patients must be at first recurrence of GBM and must not have had prior
anti-VEGF therapy.

- For Arm C: patients may have had an unlimited number of prior therapies for GBM,
however must be at first recurrence from a therapeutic regimen containing bevacizumab

- Progressive disease on contrast-enhanced brain CT or MRI as defined by McDonald
Criteria, or have documented recurrent glioblastoma on diagnostic biopsy.

- Prior to enrollment, there must be an interval of at least 2 weeks between prior
surgical resection (1 week for intracranial biopsy) and adequate wound healing.

- Interval of at least 12 weeks from prior radiotherapy unless there is either: a)
histopathologic confirmation of recurrent tumor, or b) new enhancement on MRI outside
of XRT treatment field.

- Patients must have sufficient time to recover from prior therapy.

- Karnofsky Performance Score 70% or greater

- Adequate hematologic and liver function as outlined in the protocol

- Creatinine within normal institutional limits

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation and for at least 3
months thereafter.

Exclusion Criteria:

- Presence of extra-cranial metastatic disease

- Participants may not be receiving any other investigational agents

- Prior investigational therapy with an agent that is known or proposed to be active by
action on any component of the EGFR tyrosine kinase, IGF1R, mTor, orc-MET pathways

- Patients who have been previously treated with an anti-VEGF agent will be excluded
from Arm A and Arm B.

- Patients must not have received prior Gliadel wafers

- For participants in Arm A, if the diagnostic pathology of the biopsy specimen is not
consistent with recurrent glioblastoma, then the participant must be taken off study
and be replaced with another participant that meets the inclusion criteria and is
eligible for surgical resection.

- Any surgery (not including minor diagnostic procedures such as lymph node biopsy)
within 2 weeks of baseline disease assessments; or not fully recovered from any side
effects of previous procedures.

- Any clinically significant gastrointestinal abnormalities, which may impair intake,
transit or absorption of the study drug.

- Any psychiatric or cognitive disorder that would limit the understanding or rendering
of informed consent and/or compromise compliance with the requirements of this

- Patients with known interstitial lung disease

- Uncontrolled or significant cardiovascular disease

- Any patient with a history of significant cardiovascular disease, even if currently
controlled, or who has signs or symptoms suggesting impaired left ventricular
function in the judgment of the investigator must have a screening left ventricular
ejection fraction evaluation by ECHO or MUGA. Patients with LVEF measurements below
local institutional lower limit of normal or less then 50% will not be eligible.

- Individuals with a history of a different malignancy are ineligible except for the
circumstances outlined in the protocol

- Patients who have had prior stereotactic radiotherapy, convection enhanced delivery
or brachytherapy as gliosis/scarring from these modalities may limit delivery

- Patients will not be eligible if they present with leptomeningeal dissemination

- Pregnant women

- HIV-positive individuals on combination antiretroviral therapy are ineligible

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PF-00299804

- Other severe acute or chronic medical condition, uncontrolled intercurrent illness or
laboratory abnormality that may increase the risk associated with trial participation
or investigation product administration or may interfere with the interpretation of
trial results and, in the judgment of the investigator, would make the patient
inappropriate for entry into this trial.
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