Study of Oral AEE788 in Adults With Advanced Cancer

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: AEE788

• Registration Number: NCT00118456
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2005-07-01
• Study First Submitted QC: 2005-07-01
• Study First Posted: 2005-07-11
• Primary Completion: 2008-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-05
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	AEE788	Monday, Wednesday, Friday Dosing
1	AEE788	Continuous daily dosing

Primary Outcome Measures

Name	Time	Method
Maximum-tolerated dose and dose-limiting toxicity of AEE788	4.5 years
Maximum-tolerated dose, safety and tolerability of AEE788	4.5 years

Secondary Outcome Measures

Name	Time	Method
Single dose and repeated dose pharmacokinetic profile of AEE788	4.5 years
Changes in glucose metabolism/cell viability	4.5 years
Pharmacodynamic effects	4.5 years

Trial Locations

Locations (5)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Institute of Drug Development/Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States