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

Novartis

Status and phase: Completed; Phase 2

Conditions: Dermatofibrosarcoma; Systemic Mastocytosis; Hypereosinophilic Syndrome; Chronic Myelomonocytic Leukemia

Treatments: Drug: imatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171912

CSTI571BAU12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No 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.

Other protocol-defined inclusion / exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

imatinib mesylate (STI571)

Experimental group

Treatment:

Drug: imatinib mesylate