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

NCT ID: NCT00171912

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2012-01-31

Brief 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.

Conditions

Hypereosinophilic Syndrome; Systemic Mastocytosis; Chronic Myelomonocytic Leukemia; Dermatofibrosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

imatinib mesylate (STI571)

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Interventions

imatinib mesylate

Intervention Type: DRUG

Other Intervention Names

STI571

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

Novartis Investigative Site

East Melbourne, , Australia

Countries

Australia

Other Identifiers

CSTI571BAU12

Identifier Type: -

Identifier Source: org_study_id