Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171912

Purpose

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	Intervention	Phase
Hypereosinophilic Syndrome Systemic Mastocytosis Chronic Myelomonocytic Leukemia Dermatofibrosarcoma	Drug: imatinib mesylate	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Imatinib Imatinib mesylate Tyrosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Further study details as provided by Novartis:

Primary Outcome Measures:

To assess the efficacy and the safety of imatinib mesylate therapy

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171912

Contacts

Contact: Novartis

+41 61 324 1111

Locations

Australia
	Recruiting
East Melbourne, Australia

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSTI571BAU12
Study First Received:	September 13, 2005
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00171912
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

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.

Study placed in the following topic categories:

Fibrosarcoma
Idiopathic hypereosinophilic syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Malignant mesenchymal tumor
Leukocyte Disorders
Mast cell disease
Soft tissue sarcomas
Dermatofibrosarcoma protuberans
Leukemia
Neoplasms, Connective and Soft Tissue
Lung Neoplasms
Hypereosinophilic Syndrome
Skin Diseases
Hematologic Diseases

Leukemia, Myelomonocytic, Chronic
Myeloproliferative Disorders
Systemic mastocytosis
Leukemia, Myeloid
Hypereosinophilic syndrome
Dermatofibrosarcoma
Eosinophilia
Imatinib
Leukemia, Myelomonocytic, Acute
Myelodysplastic myeloproliferative disease
Mastocytosis, Systemic
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Sarcoma
Mastocytoma
Mastocytosis

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on January 16, 2009