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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Arno Therapeutics

Current Primary Outcome:

  • Determine the 6-month Progression free survival (PFS) AR-67 is administered in adults with confirmed recurrence of GBM who have not recently (> 90 days) recurred after treatment bevacizumab. [ Time Frame: 6 month PFS ]
    Thirty-two (32) patients will be accrued to the non-bevacizumab failure cohort.
  • The primary objective in the rapid bevacizumab failure group (< 90 days) is to determine the 2-month PFS. [ Time Frame: 2 month PFS ]
    26 subjects will be enrolled in the second cohort (Rapid Avastin Progressors).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the effect of AR-67 on overall survival (OS) [ Time Frame: 1 year ]
  • the effect of AR-67 on overall PFS [ Time Frame: 6 Months ]
  • the effect of AR-67 on event-free survival (EFS) [ Time Frame: 6 Months ]
  • the impact of AR-67 on tumor response in patients with measurable disease [ Time Frame: 6 Months ]
  • the safety and tolerability of AR-67 [ Time Frame: 6 Months ]


Original Secondary Outcome: Same as current

Information By: Arno Therapeutics

Dates:
Date Received: May 12, 2010
Date Started: December 2009
Date Completion: February 2015
Last Updated: December 8, 2014
Last Verified: January 2014