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

November 7, 2015 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • North Carolina
      • Box 3624 DUMC, Trent Drive, Durham, North Carolina, United States, 27710
        • The Brain Tumor Center at Duke, Duke University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose
Time Frame: 2 years
2 years
Dose limiting toxicity
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 28, 2005

First Submitted That Met QC Criteria

June 28, 2005

First Posted (Estimate)

June 29, 2005

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 7, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEE788A2103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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