Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:7/8/2017
Start Date:April 2, 2013
End Date:June 19, 2017

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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with
glioblastoma multiforme.


Inclusion Criteria:

1. Glioblastoma Multiforme (GBM)

2. 70 or above on Karnofsky Performance Status

3. Adequate bone marrow function

4. Recurrent GBM per RANO criteria

5. Subjects must have confirmed EGFR amplification by central lab

Exclusion Criteria:

1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with
bevacizumab, nitrosourea, or has secondary GBM

2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with
bevacizumab, or has secondary GBM

3. Allergies to temozolomide, dacarbazine, IgG containing agents

4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort
temozolomide therapy is allowed

5. Subjects that have had more than one disease recurrence
We found this trial at
13
sites
Boston, Massachusetts 02215
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1720 2nd Avenue South
Birmingham, Alabama 35294
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Birmingham, AL
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388 Commonwealth Avenue
Boston, Massachusetts 02215
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Boston, MA
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Brisbane,
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Detroit, Michigan 48202
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Detroit, MI
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1301 Central St
Evanston, Illinois 60201
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Evanston, IL
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1515 Holcombe Boulevard
Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90095
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Los Angeles, CA
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New York, NY
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Salt Lake City, Utah 84112
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Salt Lake City, UT
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4383 Medical Drive
San Antonio, Texas 78229
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San Antonio, TX
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505 Parnassus Avenue
San Francisco, California 94143
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San Francisco, CA
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