CompletedPhase 2

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

Australia38 participantsStarted 2004-09

Plain-language 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.

Who can participate

Age range16 Years – 80 Years

SexALL

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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.

What they're measuring

To assess the efficacy and the safety of imatinib mesylate therapy

Timeframe: 2 years

Trial details

NCT IDNCT00171912

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-01

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