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A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
||A Randomized, Placebo Controlled Phase 2b/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 (Intellance 1)
||Suriya Jeyapalan, MD
The main purposes of this study are to evaluate whether combining ABT-414 with usual RT and TMZ treatment controls GBM better than usual RT and TMZ without ABT-414, and whether ABT-414 makes patients live longer. This study will only include people whose tumors are tested and confirmed to have EGFR amplification.
- Newly diagnosed Grade IV glioma (glioblastoma multiforme, gliosarcoma, and variants)
- Tumors with EGFR amplification
- Otherwise normal organ function
- No multifocal GBM or metastatic GBM
- No prior treatment for GBM, no prior radiation for head and neck cancers
- No complicating diseases or disorders (including pregnant or lactating women)
Potential subjects will come to clinic for a screening visit where they will sign consent and undergo tests to make sure they are eligible for the study. These tests include sending a portion of their previously resected tumor tissue for EGFR analysis. In addition to standard chemoradiation (chemo is taken orally once a day and radiation occurs 5 days a week for 6 weeks), subjects will come to clinic to receive an infusion of the study drug (ABT-414 or placebo) once every 2 weeks. After chemoradiation, subjects will continue to receive study drug infusions every 2 weeks and start adjuvant chemo (adjuvant chemo is taken orally once a day for 5 days out of every 28 day cycle). Subjects will receive adjuvant chemo and study drug infusions until disease progression or 12 cycles, whichever comes first. Subjects will have MRIs, neurocognitive testing, and quality of life questionairres every 2 months. Because of the risk of eye side effects, subjects will be given eye drops to use every day from 2 days before to 5 days after every study drug infusion. Subjects will also see an ophthalmologist once a month for the first 3 months, and then every other month thereafter. If the subject shows no side effects in the eye, the drops and ophthalmologic exams may be reduced and then stopped.