Study of Oral AEE788 in Adults With Advanced Cancer | NCT00118456

Studies
Study of Oral AEE788 in Adults With Advanced Cancer

NCT00118456

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Jan 9, 2012Estimated

Enrollment

189Actual

Phase

Phase 1

Conditions

Cancer

Interventions

AEE788

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Jan 2008Actual

Completion Date

Not provided

First Submitted Date

Jul 1, 2005

First Submission Date that Met QC Criteria

Jul 1, 2005

First Posted Date

Jul 11, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2012

Last Update Posted Date

Jan 9, 2012Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

189Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Continuous daily dosing	Drug: AEE788
2	Experimental	Monday, Wednesday, Friday Dosing	Drug: AEE788

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AEE788	Drug		1 2

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Cancer Center		New Haven	Connecticut	06520	United States
Nevada Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C489254	AEE 788

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided