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

• Status: Completed
• Trial end date: 2017-06-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Dacarbazine; Temozolomide

Criteria

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