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

Phase 2CompletedNCT00171912

Novartis Pharmaceuticals38 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypereosinophilic Syndrome Systemic Mastocytosis Chronic Myelomonocytic Leukemia Dermatofibrosarcoma

Interventions

imatinib mesylateDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

East Melbourne, Australia

Outcomes

Primary Outcomes

To assess the efficacy and the safety of imatinib mesylate therapy

Time frame: 2 years

Secondary Outcomes

To evaluate the effects of imatinib on quality of life and healthcare resource use

Time frame: 2 years

Data from ClinicalTrials.gov

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