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Completed

NCT Number: NCT00171912

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

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.

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Key information

Conditions

Hypereosinophilic Syndrome Bone Marrow Diseases Chronic Disease Chronic Myelomonocytic Leukemia Dermatofibrosarcoma Disease Attributes Eosinophilia Fibrosarcoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukocyte Disorders Lung Diseases Lung Neoplasms Mast Cell Activation Disorders Mastocytosis Mastocytosis, Systemic Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Systemic Mastocytosis Thoracic Neoplasms

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

East Melbourne, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

imatinib mesylate

Drug

Other names: STI571

Primary outcomes

  1. To assess the efficacy and the safety of imatinib mesylate therapy

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Sep 15, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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