Study of AEE788 in Patients With Recurrent/Relapse Gliobl... | NCT00116376

Studies
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

NCT00116376

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Nov 10, 2015Estimated

Enrollment

64Actual

Phase

Phase 1Phase 2

Conditions

Glioblastoma Multiforme

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

Status Module

Record Verification Date

Nov 2015

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

Jan 2004

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Jun 28, 2005

First Submission Date that Met QC Criteria

Jun 28, 2005

First Posted Date

Jun 29, 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

Nov 7, 2015

Last Update Posted Date

Nov 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the 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/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Label	Type	Description	Intervention Names
AEE788 + non EIACD	Experimental		Drug: AEE788
AEE788 + EIACD	Experimental		Drug: AEE788

Name	Type	Description	Arm Group Labels	Other Names
AEE788	Drug		AEE788 + EIACD AEE788 + non EIACD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum tolerated dose		2 years
Dose limiting toxicity		2 years

Secondary Outcomes

Measure	Description	Time Frame
Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed GBM in first or second recurrence or relapse
Adequate hematologic, hepatic and renal function
Age ≥ 18 years
Karnofsky performance status score ≥ 70%
Life expectancy ≥ 12 weeks

Exclusion Criteria:

Peripheral neuropathy > grade 1
Diarrhea > grade 1
Gastrointestinal 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
David Reardon, MD	Duke University	Principal Investigator
Charles Conrad, MD	M.D. Anderson Cancer Center	Principal Investigator
Timothy Cloughesy, MD	University of California, Los Angeles	Principal Investigator
Michael Prados, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California at Los Angeles		Los Angeles	California	90095	United States
University of California, San Francisco

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma
D012008	Recurrence

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

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