AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme
Recruitment status was: Recruiting
Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels.
Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1b/2a, Multicenter, Open-Label Study of AQ4N in Combination With Radiation Therapy and Temozolomide, to Evaluate the Safety, Tolerability, and Efficacy in Subjects With Newly Diagnosed Glioblastoma Multiforme|
- Phase 1b: Evaluation of the safety and tolerability of AQ4N in combination with radiation therapy and temozolomide (TEMODAR®)for the treatment of glioblastoma multiforme (GBM). Dose levels for the Phase 2a will be selected.
- Phase 2a: Rate of progression-free survival at 6 months.
- Phase 2a: Rate of progression-free survival at 12 months
- Percent of subjects alive at 12 months
- Duration of progression-free survival
- Time to progression
- Duration of overall survival
|Study Start Date:||October 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394628
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|Henry Ford Health Systems|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|Baylor Research Institute|
|Dallas, Texas, United States|