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
We found this trial at
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Boston, Massachusetts 02215
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Atlanta, Georgia 30309
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Atlanta, Georgia 30322
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12201 Renfert Way
Austin, Texas 78758
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801 Ostrum Street
Bethlehem, Pennsylvania 18015
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800 Meadows Road
Boca Raton, Florida 33486
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Boston, Massachusetts 02111
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Boston, Massachusetts 02114
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Buenos Aires,
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400 Haddon Avenue
Camden, New Jersey 08103
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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Charlotte, North Carolina 28204
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Chicago, Illinois 60637
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Cincinnati, Ohio 45267
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Cleveland, Ohio 44106
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9500 Euclid Avenue
Cleveland, Ohio 44195
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3410 Worth Street
Dallas, Texas 75246
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Detroit, Michigan 48201
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Detroit, Michigan 48202
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Fairfield, Connecticut 06824
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Falls Church, Virginia 22042
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3232 North Northhills Boulevard
Fayetteville, Arkansas 72703
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Fort Lauderdale, Florida 33308
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Fort Wayne, Indiana 46805
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500 University Drive
Hershey, Pennsylvania 17033
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Los Angeles, California 90033
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600 Highland Avenue
Madison, Wisconsin 53792
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Miami, Florida 33176
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Milwaukee, Wisconsin 53226
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5121 Cottonwood Street
Murray, Utah 84157
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New Brunswick, New Jersey 08903
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2520 North Orange Avenue
Orlando, Florida 32804
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Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19111
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350 West Thomas Road
Phoenix, Arizona 85013
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320 East North Avenue
Pittsburgh, Pennsylvania 15212
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Rochester, New York 14642
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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San Francisco, California 94143
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Seattle, Washington 98101
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