Cancer types
  • Neuro-oncology
Title of study
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)
Version Number
Approval Date 
RTOG 3508, Amendment 5, 13 January 2017
Short Title
M13-813
Study site
Principle Investigator
Andrew B. Lassman, MD (Columbia University Medical Center)
Investigator Maastro
Dr. A. Hoeben (Maastricht UMC+)
Sponsor
AbbVie
Trial registry
Objectives 

• Phase 2b: To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs Progression Free Survival (PFS) among subjects with newly diagnosed GBM harboring EGFR amplification.
• Phase 3: To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs Overall Survival (OS) among subjects withnewly diagnosed GBM harboring EGFR amplification.

Primary Endpoint 

• Progression Free Survival (PFS) for Phase 2b
• Overall Survival (OS) for Phase 3

Secondary Endpoints 

• Overall Survival (OS) for Phase 2b
• Progression Free Survival (PFS) for Phase 3