Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Phase 2

Completed

• Conditions: Systemic Mastocytosis; Hypereosinophilic Syndrome; Chronic Myelomonocytic Leukemia; Dermatofibrosarcoma
• Interventions: Drug: imatinib mesylate

• Registration Number: NCT00171912
• Lead Sponsor: Novartis Pharmaceuticals

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 these enzymes and to assess the effect on the malignancy.

Detailed Description

Condition

Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.

Not included:

Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
2. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
3. 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 Criteria

1. Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
2. A primary prostate, breast, lung or brain tumour,
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imatinib mesylate (STI571)	imatinib mesylate	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy and the safety of imatinib mesylate therapy	2 years

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of imatinib on quality of life and healthcare resource use	2 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇺 East Melbourne, Australia