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

Novartis Pharmaceuticals64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme

Interventions

AEE788DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

University of California at Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, 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

Outcomes

Primary Outcomes

Maximum tolerated dose

Time frame: 2 years

Dose limiting toxicity

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2 years

Data from ClinicalTrials.gov

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