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)

Protocol: 
AAAQ2302
Phase: 
II/III

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)

This is a Phase 2b/3 study to compare the effectiveness of the study drug ABT-414 against a placebo. Patients will be randomized to either receive the standard-of-care therapy which consists of ratiation therapy/TMZ plus adjuvant TMZ which will be followed by eiter the study drug ABT-414 or a placebo monotherapy.

Are you Eligible? (Inclusion Criteria)

1. Histologically confirmed de novo Grade IV glioma (GBM, gliosarcoma or other subvariants) confirmed by central pathology tissue screening.
2. EGFR amplification in tumor tissue confirmed by central assessment.
3. Supratentorial tumor.
4. The subject must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment including suture/staple removal from brain surgery and sufficient wound healing before step 2 registration. Post-operative contrast-enhanced MRI scan must be done within 72 hours after surgery.
5. ≥ 18 years of age.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States