Status:
COMPLETED
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
Lead Sponsor:
AbbVie
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
Eligibility Criteria
Inclusion
- Glioblastoma Multiforme (GBM)
- 70 or above on Karnofsky Performance Status
- Adequate bone marrow function
- Recurrent GBM per RANO criteria
- Subjects must have confirmed EGFR amplification by central lab
Exclusion
- For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
- For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
- Allergies to temozolomide, dacarbazine, IgG containing agents
- Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
- Subjects that have had more than one disease recurrence
Key Trial Info
Start Date :
April 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2017
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT01800695
Start Date
April 2 2013
End Date
June 19 2017
Last Update
November 21 2017
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