Study of Oral AEE788 in Adults With Advanced Cancer

Completed · Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00118456

Run by

Novartis Pharmaceuticals

People needed

189

Starts

2003-07-01

Last updated by the study team

2012-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Institute of Drug Development/Cancer Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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