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Clinical Trials/NCT00171860
NCT00171860
Terminated
Phase 2

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

Novartis Pharmaceuticals1 site in 1 country24 target enrollmentSeptember 2002
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ConditionsHypereosinophilic Syndrome
Interventionsimatinib mesylate
Drugsimatinib mesylate

Overview

Phase
Phase 2
Intervention
imatinib mesylate
Conditions
Hypereosinophilic Syndrome
Sponsor
Novartis Pharmaceuticals
Enrollment
24
Locations
1
Primary Endpoint
Rate of complete and partial response and relapse
Status
Terminated
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The objectives of the study are:

  1. 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.
  2. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
  3. Analysis of patient's blood samples for the detection of activated kinases.
Registry
clinicaltrials.gov
Start Date
September 2002
End Date
July 2007
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

STI571

Intervention: imatinib mesylate

Outcomes

Primary Outcomes

Rate of complete and partial response and relapse

Secondary Outcomes

  • Bone Marrow Analysis
  • Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
  • Disease-Related Symptoms and Signs
  • Organ Involvement

Study Sites (1)

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