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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171912

Enrollment

Registered

2005-09-15

Start date

2004-09-30

Completion date

2012-01-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelomonocytic Leukemia, Dermatofibrosarcoma, Hypereosinophilic Syndrome, Systemic Mastocytosis

Keywords

Imatinib mesylate, tyrosine kinases, imatinib sensitivity, 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.

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.

Interventions

DRUGimatinib mesylate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 80 Years

Healthy volunteers

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 /

Design outcomes

Primary

Measure	Time frame
To assess the efficacy and the safety of imatinib mesylate therapy	2 years

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026