A Study to Determine the Safety and Efficacy of Imatinib... | NCT00171860

Studies
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

NCT00171860

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

May 1, 2012Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Hypereosinophilic Syndrome

Interventions

imatinib mesylate

Countries

Belgium

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Jul 2007Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 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

Apr 29, 2012

Last Update Posted Date

May 1, 2012Estimated

Description Module

Brief Summary

The objectives of the study are:

Evaluation of the safety profile of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone, hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion protein.
Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
Analysis of patient's blood samples for the detection of activated kinases.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Label	Type	Description	Intervention Names
STI571	Experimental		Drug: imatinib mesylate

Name	Type	Description	Arm Group Labels	Other Names
imatinib mesylate	Drug		STI571	Gleevec/Glivec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of complete and partial response and relapse

Secondary Outcomes

Measure	Description	Time Frame
Bone Marrow Analysis
Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
Disease-Related Symptoms and Signs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories:

previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha.
not previously treated but with documented Fip1L1-PDGFRA fusion protein

Exclusion Criteria:

Other diseases associated with hypereosinophilia
Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit.
ECOG performance status >3

Other protocol-defined exclusion criteria may apply.

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
Novartis Investigative Site		Leuven			Belgium

Condition Browse Module

MeSH Terms

ID	Term
D017681	Hypereosinophilic Syndrome

Ancestor Terms

ID	Term
D004802	Eosinophilia
D007960	Leukocyte Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided