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

Use our guide to learn which trials are right for you!

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
70
sites
9500 Euclid Avenue
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
12201 Renfert Way
Austin, Texas 78758
?
mi
from
Austin, TX
Click here to add this to my saved trials
801 Ostrum Street
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
800 Meadows Road
Boca Raton, Florida 33486
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
400 Haddon Avenue
Camden, New Jersey 08103
?
mi
from
Camden, NJ
Click here to add this to my saved trials
96 Jonathan Lucas Street
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45267
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3410 Worth Street
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fairfield, Connecticut 06824
?
mi
from
Fairfield, CT
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
3232 North Northhills Boulevard
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Wayne, Indiana 46805
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Geneva, IL
Click here to add this to my saved trials
500 University Drive
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
600 Highland Avenue
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
5121 Cottonwood Street
Murray, Utah 84157
?
mi
from
Murray, UT
Click here to add this to my saved trials
New Brunswick, New Jersey 08903
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, DE
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
2520 North Orange Avenue
Orlando, Florida 32804
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
350 West Thomas Road
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
320 East North Avenue
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14642
?
mi
from
Rochester, NY
Click here to add this to my saved trials
660 South Euclid Avenue
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis Park, Minnesota 55416
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
7901 Frost Street
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
505 Parnassus Avenue
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
1100 9th Avenue
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98195
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
3000 Arlington Avenue
Toledo, Ohio 43614
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Warrenville, IL
Click here to add this to my saved trials
?
mi
from
West Hollywood, CA
Click here to add this to my saved trials
?
mi
from
Westwood, KS
Click here to add this to my saved trials
Ypsilanti, Michigan 48106
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials