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

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ClinicalTrials.gov Identifier: NCT00171912
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Hypereosinophilic Syndrome Systemic Mastocytosis Chronic Myelomonocytic Leukemia Dermatofibrosarcoma Drug: imatinib mesylate Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
Study Start Date : September 2004
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012


Arm Intervention/treatment
Experimental: imatinib mesylate (STI571) Drug: imatinib mesylate
Other Name: STI571




Primary Outcome Measures :
  1. To assess the efficacy and the safety of imatinib mesylate therapy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate the effects of imatinib on quality of life and healthcare resource use [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171912


Locations
Australia
Novartis Investigative Site
East Melbourne, Australia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171912     History of Changes
Other Study ID Numbers: CSTI571BAU12
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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.

Additional relevant MeSH terms:
Leukemia
Neoplasms
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Mastocytosis
Mastocytosis, Systemic
Hypereosinophilic Syndrome
Dermatofibrosarcoma
Neoplasms by Histologic Type
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Skin Diseases
Eosinophilia
Leukocyte Disorders
Fibrosarcoma
Neoplasms, Fibrous Tissue
Sarcoma
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action