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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00171912




Registration number
NCT00171912
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
23/02/2017

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
CSTI571BAU12
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
Allocation to intervention
N/A
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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
38
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
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00171912
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00171912