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

NCT01124539 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-12-09

No results posted yet for this study

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

Interventions

DRUG

AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin)

IV AR-67 administered once daily for 5 days on an every 21-day cycle

Sponsors & Collaborators

  • Arno Therapeutics

    lead INDUSTRY

Principal Investigators

  • James J Vredneburgh, MD · Duke University Medical Center - The Preston Robert Tisch Brain Tumor Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-09-30
Completion
2015-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124539 on ClinicalTrials.gov