Study of Oral AEE788 in Adults With Advanced Cancer

NCT ID: NCT00118456

Last Updated: 2012-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Brief Summary

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AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against 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 (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Continuous daily dosing

Group Type EXPERIMENTAL

AEE788

Intervention Type DRUG

2

Monday, Wednesday, Friday Dosing

Group Type EXPERIMENTAL

AEE788

Intervention Type DRUG

Interventions

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AEE788

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed solid tumor
* Adequate hematologic, renal and hepatic function
* Age ≥ 18 years
* Karnofsky performance status score ≥ 70%
* Life expectancy ≥ 12 weeks

Exclusion Criteria

* Active brain metastases
* Peripheral neuropathy \> grade 2
* Diarrhea \> grade 1
* Gastrointestinal (GI) dysfunction
* Compromised cardiac function
* Concurrent severe and/or uncontrolled medical conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Nevada Cancer Institute

Las Vegas, Nevada, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Institute of Drug Development/Cancer Therapy and Research Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CAEE788A2101

Identifier Type: -

Identifier Source: org_study_id

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