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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
Not Enrolling
Both
Glioblastoma Multiforme

Thank you

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