Status:

COMPLETED

Study of Oral AEE788 in Adults With Advanced Cancer

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 les...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

July 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

189 Patients enrolled

Trial Details

Trial ID

NCT00118456

Start Date

July 1 2003

Last Update

January 9 2012

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Yale Cancer Center

New Haven, Connecticut, United States, 06520

2

Nevada Cancer Institute

Las Vegas, Nevada, United States, 89125

3

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

4

MD Anderson Cancer Center

Houston, Texas, United States, 77054