NCT01124539

Study of AR-67 in Adult Patients With Recurrence of Glioblastoma Multiforme (GBM) or Gliosarcoma

A Phase 2 Study of AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin) in Adult Patients With Recurrence of Glioblastoma Multiforme (GBM) or Gliosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Arno Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the 6-month Progression free survival (PFS) when intravenous (IV) AR-67 is administered in adults with confirmed recurrence of GBM who have not recently (\> 90 days) recurred after treatment bevacizumab (including patients who've received temazolamide, but no bevacizumab). The primary objective in the rapid bevacizumab failure group (\< 90 days) is to determine the 2-month PFS.

Conditions

• Glioblastoma Multiforme
• GBM
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin)	IV AR-67 administered once daily for 5 days on an every 21-day cycle

Timeline

• Start date: 2009-12-01
• Primary completion: 2014-09-01
• Completion: 2015-02-01
• First posted: 2010-05-17
• Last updated: 2014-12-09

Locations

9 sites across 2 countries: United States, Canada