Cancer
Conditions
Keywords
Advanced cancers, EGFR, Her2, VEGFR
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.
Interventions
DRUGAEE788
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum-tolerated dose and dose-limiting toxicity of AEE788 | 4.5 years |
| Maximum-tolerated dose, safety and tolerability of AEE788 | 4.5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed