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

Primary Purpose

Hypereosinophilic Syndrome, Systemic Mastocytosis, Chronic Myelomonocytic Leukemia

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

imatinib mesylate

About this trial

This is an interventional treatment trial for Hypereosinophilic Syndrome focused on measuring 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.

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Other protocol-defined inclusion / exclusion criteria may apply.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

imatinib mesylate (STI571)

Arm Description

Outcomes

Primary Outcome Measures

To assess the efficacy and the safety of imatinib mesylate therapy

Secondary Outcome Measures

To evaluate the effects of imatinib on quality of life and healthcare resource use

Full Information

NCT ID

NCT00171912

First Posted

September 13, 2005

Last Updated

February 21, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00171912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

imatinib mesylate (STI571)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

imatinib mesylate

Other Intervention Name(s)

STI571

Primary Outcome Measure Information:

Title

To assess the efficacy and the safety of imatinib mesylate therapy

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To evaluate the effects of imatinib on quality of life and healthcare resource use

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

East Melbourne

Country

Australia

12. IPD Sharing Statement

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

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