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

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AEE788

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring GBM, recurrent/relapse, EGFR, VEGFR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of California at Los Angeles
University of California, San Francisco
The Brain Tumor Center at Duke, Duke University Medical Center
University of Texas, MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AEE788 + non EIACD

AEE788 + EIACD

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose

Dose limiting toxicity

Secondary Outcome Measures

Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels

Full Information

NCT ID

NCT00116376

First Posted

June 28, 2005

Last Updated

November 7, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00116376

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

Keywords

GBM, recurrent/relapse, EGFR, VEGFR

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AEE788 + non EIACD

Arm Type

Experimental

Arm Title

AEE788 + EIACD

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AEE788

Primary Outcome Measure Information:

Title

Maximum tolerated dose

Time Frame

2 years

Title

Dose limiting toxicity

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Reardon, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Charles Conrad, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Timothy Cloughesy, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Prados, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California at Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

The Brain Tumor Center at Duke, Duke University Medical Center

City

Box 3624 DUMC, Trent Drive, Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

University of Texas, MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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