A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/7/2019
Start Date:December 7, 2015
End Date:July 24, 2021
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and
temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall
survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal
growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the
pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed
EGFR-amplified GBM who have mild or moderate hepatic impairment.

The main study for all countries except China is closed. The sub-study of ABT-414 in
participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic
impairment is open to enrollment.


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 glimatosis 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
therapy
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Boston, Massachusetts 02215
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Atlanta, Georgia 30309
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