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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
Scientific title
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypereosinophilic Syndrome 0 0
Systemic Mastocytosis 0 0
Chronic Myelomonocytic Leukemia 0 0
Dermatofibrosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Skin 0 0 0 0
Other skin conditions
Blood 0 0 0 0
Other blood disorders
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Blood 0 0 0 0
Haematological diseases

Study type
Description of intervention(s) / exposure
Treatment: Drugs - imatinib mesylate

Experimental: imatinib mesylate (STI571) -

Treatment: Drugs: imatinib mesylate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
To assess the efficacy and the safety of imatinib mesylate therapy
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
To evaluate the effects of imatinib on quality of life and healthcare resource use
Timepoint [1] 0 0
2 years

Key inclusion criteria
1. Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib

2. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the

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.
Minimum age
16 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Novartis Pharmaceuticals

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmeceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications