Clinical Trial Details
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NCT02573324 : A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification ( Intellance1 )
PhasePhase 3
AgesMin: 18 Years Max: 99 Years
Inclusion Criteria:

1. Must have a clinical diagnosis of Glioblastoma (GBM)

2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue

3. Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to
randomization (N/A to the sub-study).

4. Must have recovered from effects of surgery, postoperative infection and other
complications of surgery

5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the
subject must have adequate bone marrow and renal function and have mild-to-moderate
hepatic impairment)

Exclusion Criteria:

1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the
sub-study, the subject can have multifocal GBM and gliomatosis cerebri but can't have
recurrent or metastatic GBM)

2. Prior chemo therapy or radiosensitizer for head and neck cancer

3. Prior radiotherapy to the head or neck in overlap of radiation fields

4. Prior therapy for glioblastoma or other invasive malignancy

5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy,
bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic
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