Study of Oral AEE788 in Adults With Advanced Cancer

Novartis

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: AEE788

Study type: Interventional

Funder types: Industry

Identifiers

NCT00118456

CAEE788A2101

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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189 participants in 2 patient groups

1

Experimental group

Description:

Continuous daily dosing

Treatment:

Drug: AEE788

2

Experimental group

Description:

Monday, Wednesday, Friday Dosing

Treatment:

Drug: AEE788