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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00116376

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Drug: AEE788	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AEE788 + non EIACD	Drug: AEE788
Experimental: AEE788 + EIACD	Drug: AEE788

Arm

Intervention/Treatment

Experimental: AEE788 + non EIACD

Drug: AEE788

Experimental: AEE788 + EIACD

Drug: AEE788

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose [2 years]
Dose limiting toxicity [2 years]

Secondary Outcome Measures

Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at Los Angeles	Los Angeles	California	United States	90095
2	University of California, San Francisco	San Francisco	California	United States	94143
3	The Brain Tumor Center at Duke, Duke University Medical Center	Box 3624 DUMC, Trent Drive, Durham	North Carolina	United States	27710
4	University of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Principal Investigator: David Reardon, MD, Duke University
Principal Investigator: Charles Conrad, MD, M.D. Anderson Cancer Center
Principal Investigator: Timothy Cloughesy, MD, University of California, Los Angeles
Principal Investigator: Michael Prados, MD, University of California, San Francisco