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


Phase 2
16 Years
80 Years
Not Enrolling
Both
Hypereosinophilic Syndrome, Systemic Mastocytosis, Chronic Myelomonocytic Leukemia, Dermatofibrosarcoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy and the safety of imatinib mesylate therapy

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CSTI571BAU12

NCT ID:

NCT00171912

Start Date:

September 2004

Completion Date:

January 2012

Related Keywords:

  • Hypereosinophilic Syndrome
  • Systemic Mastocytosis
  • Chronic Myelomonocytic Leukemia
  • Dermatofibrosarcoma
  • 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.
  • Neoplasms
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma
  • Leukemia, Myelomonocytic, Acute
  • Hypereosinophilic Syndrome
  • Dermatofibrosarcoma
  • Mastocytosis, Systemic

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