A Randomized, Placebo Controlled Phase 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 (Intellance1)
A Randomized, Placebo Controlled Phase 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 (Intellance1)
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.
In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
Inclusion Criteria:
Exclusion Criteria:
West Hollywood, California 90048, United States
Chicago, Illinois 60611-2927, United States
Warrenville, Illinois 60555, United States
Hershey, Pennsylvania 17033, United States
Pittsburgh, Pennsylvania 15232, United States
Houston, Texas 77030, United States
Richmond, Virginia 23219, United States
Fitzroy Melbourne, Victoria 3065, Australia
Innsbruck, 6020, Austria
São Paulo, São Paulo 01246-000, Brazil
Rio de Janeiro, 20231-050, Brazil
Montreal, Quebec H4A 3J1, Canada
Beijing, Beijing Municipality 100042, China
Shanghai, Shanghai Municipality 200040, China
Bogota, Cundinamarca 110221, Colombia
Montería, Departamento de Córdoba 230002, Colombia
Saint-Herblain, Loire-Atlantique 44805, France
Wellington, 6021, New Zealand
Lisbon, 1649-035, Portugal
Kaliningrad, Kaliningrad Oblast 236016, Russia
Ufa, Kirov Oblast 450054, Russia
Moscow, Moscow 115478, Russia
Moscow, Moscow 125047, Russia
Moscow, Moscow Oblast 129090, Russia
Bloemfontein, Free State 9301, South Africa
Seoul, Seoul Teugbyeolsi 03722, South Korea
Newcastle upon Tyne, NE7 7DN, United Kingdom