Status:
COMPLETED
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypereosinophilic Syndrome
Systemic Mastocytosis
Eligibility:
All Genders
16-80 years
Phase:
PHASE2
Brief Summary
This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks thes...
Detailed Description
Condition Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocy...
Eligibility Criteria
Inclusion
- Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
- Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
- Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) \& preferably within 6 weeks of entry.
Exclusion
- Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
- A primary prostate, breast, lung or brain tumour,
- Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.
- Other protocol-defined inclusion / exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00171912
Start Date
September 1 2004
End Date
January 1 2012
Last Update
February 23 2017
Active Locations (1)
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1
Novartis Investigative Site
East Melbourne, Australia