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CompletedNCT00171912Updated Feb 23, 2017

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

A Phase 2 interventional study of imatinib mesylate in Hypereosinophilic Syndrome, Systemic Mastocytosis and Chronic Myelomonocytic Leukemia, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Australia. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypereosinophilic Syndrome
  • Systemic Mastocytosis
  • Chronic Myelomonocytic Leukemia
  • Dermatofibrosarcoma

Keywords

  • 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.
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 38 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    imatinib mesylate (STI571)

    Drug: imatinib mesylate

Interventions

  • Drugimatinib mesylate

    Also known as: STI571

06

What researchers measure

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

07

Study locations

1 site
  • Novartis Investigative Site
    East Melbourne, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00171912
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Sep 2004
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Feb 23, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmeceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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