NCT00118456

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_1 cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

January 9, 2012

Status Verified

January 1, 2012

Enrollment Period

4.5 years

First QC Date

July 1, 2005

Last Update Submit

January 5, 2012

Conditions

Cancer

Keywords

Advanced cancersEGFRHer2VEGFR

Outcome Measures

Primary Outcomes (2)

  • Maximum-tolerated dose and dose-limiting toxicity of AEE788

    4.5 years

  • Maximum-tolerated dose, safety and tolerability of AEE788

    4.5 years

Secondary Outcomes (3)

  • Single dose and repeated dose pharmacokinetic profile of AEE788

    4.5 years

  • Pharmacodynamic effects

    4.5 years

  • Changes in glucose metabolism/cell viability

    4.5 years

Study Arms (2)

1

EXPERIMENTAL

Continuous daily dosing

Drug: AEE788

2

EXPERIMENTAL

Monday, Wednesday, Friday Dosing

Drug: AEE788

Interventions

AEE788DRUG
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89125, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77054, United States

Location

Institute of Drug Development/Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AEE 788

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 11, 2005

Study Start

July 1, 2003

Primary Completion

January 1, 2008

Last Updated

January 9, 2012

Record last verified: 2012-01

Locations

US(5)