Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116376
• Other study ID #: CAEE788A2103
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 28, 2005
• Last updated: November 7, 2015
• Start date: January 2004
• Est. completion date: November 2005

Study information

• Verified date: November 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.

Other known NCT identifiers

• NCT00085215

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• AEE788

Locations

Country	Name	City	State
United States	The Brain Tumor Center at Duke, Duke University Medical Center	Box 3624 DUMC, Trent Drive, Durham	North Carolina
United States	University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	University of California at Los Angeles	Los Angeles	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		2 years	Yes
Primary	Dose limiting toxicity		2 years	Yes
Secondary	Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels		2 years	No