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COMPLETEDPHASE2

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

NCT00171912•Novartis Pharmaceuticals

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.

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

Age

16 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Novartis Investigative Site

East Melbourne, Australia

Key Dates

Start Date

September 1, 2004

Primary Completion Date

January 1, 2012

Completion Date

January 1, 2012

Last Updated

February 23, 2017

Enrollment

ACTUAL participants

Conditions

Hypereosinophilic SyndromeSystemic MastocytosisChronic Myelomonocytic LeukemiaDermatofibrosarcoma

Interventions

imatinib mesylate

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes