A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme
Both
Glioblastoma Multiforme
Trial Information
A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme
Inclusion Criteria:
- Histologically confirmed GBM in first or second recurrence or relapse
- Adequate hematologic, hepatic and renal function
- Age ≥ 18 years
- Karnofsky performance status score ≥ 70%
- Life expectancy ≥ 12 weeks
Exclusion Criteria:
- Peripheral neuropathy > grade 1
- Diarrhea > grade 1
- Gastrointestinal dysfunction
- Compromised cardiac function
- Concurrent severe and/or uncontrolled medical conditions
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
David Reardon, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke University
Authority:
United States: Food and Drug Administration
Study ID:
CAEE788A2103
NCT ID:
NCT00116376
Start Date:
January 2004
Completion Date:
Related Keywords:
- Glioblastoma Multiforme
- GBM
- recurrent/relapse
- EGFR
- VEGFR
- Glioblastoma
Name | Location |
|---|---|
| University of California, San Francisco | San Francisco, California 94143 |
| University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |
| University of California at Los Angeles | Los Angeles, California 90095 |
| The Brain Tumor Center at Duke, Duke University Medical Center | Durham, North Carolina 27710 |
