Study of Oral AEE788 in Adults With Advanced Cancer

Cancer Clinical Trial

Official title:

A Phase I/II, Multicenter, Randomized Dose-Escalation Study of Oral AEE788 on Intermittent Dosing Schedules in Adult Patients With Advanced Cancer (Effective Amendment 5) Previously Entitled A Phase IA, Multicenter, Dose-Escalating Study of Oral AEE788 on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118456
• Other study ID #: CAEE788A2101
• Status: Completed
• Phase: Phase 1
• First received: July 1, 2005
• Last updated: January 5, 2012
• Start date: July 2003

Study information

• Verified date: January 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• AEE788

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum-tolerated dose and dose-limiting toxicity of AEE788		4.5 years	Yes
Primary	Maximum-tolerated dose, safety and tolerability of AEE788		4.5 years	Yes
Secondary	Single dose and repeated dose pharmacokinetic profile of AEE788		4.5 years	No
Secondary	Pharmacodynamic effects		4.5 years	No
Secondary	Changes in glucose metabolism/cell viability		4.5 years	No