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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171912
First received: September 13, 2005
Last updated: November 29, 2012
Last verified: November 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To assess the efficacy and the safety of imatinib mesylate therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the effects of imatinib on quality of life and healthcare resource use [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: September 2004
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imatinib mesylate (STI571) Drug: imatinib mesylate
Other Name: STI571

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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171912     History of Changes
Other Study ID Numbers: CSTI571BAU12
Study First Received: September 13, 2005
Last Updated: November 29, 2012
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.

Additional relevant MeSH terms:
Urticaria Pigmentosa
Neoplasms
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Mastocytosis
Leukemia
Syndrome
Hypereosinophilic Syndrome
Mastocytosis, Systemic
Dermatofibrosarcoma
Leukemia, Myeloid
Neoplasms by Histologic Type
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Skin Diseases
Mastocytosis, Cutaneous
Pigmentation Disorders
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Fibrosarcoma
Neoplasms, Fibrous Tissue
Sarcoma
Imatinib
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014