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 |
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.
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
505 Parnassus Avenue
San Francisco, California 94143
San Francisco, California 94143
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1515 Holcombe Boulevard
Houston, Texas 77030
Houston, Texas 77030
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4383 Medical Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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