Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)
NCT00481455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2008-11-25
Summary
The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD given in combination with daily oral fixed-dose temozolomide in patients with recurrent glioblastoma multiforme.
Conditions
- Recurrent Glioblastoma Multiforme
Interventions
- DRUG
-
Panzem NCD
2000 mg q8h, continuous dosing in 28 day cycles
- DRUG
-
Fixed dose
Sponsors & Collaborators
-
CASI Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Annick Desjardins, MD · Duke University
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
- 2007-04-30
- Primary Completion
- 2007-09-30
- Completion
- 2008-10-31
Countries
- United States
Study Locations
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