NCT00171912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

7.3 years

First QC Date

September 13, 2005

Last Update Submit

February 21, 2017

Conditions

Hypereosinophilic SyndromeSystemic MastocytosisChronic Myelomonocytic LeukemiaDermatofibrosarcoma

Keywords

Imatinib mesylatetyrosine kinasesimatinib sensitivityDiverse malignancies either associated withor thought to be associated withactivated tyrosine kinase enzymesincluding hypereosinophilic syndromesystemic mastocytosischronic 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.

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy and the safety of imatinib mesylate therapy

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (1)

imatinib mesylate (STI571)

EXPERIMENTAL
Drug: imatinib mesylate

Interventions

imatinib mesylateDRUG
Also known as: STI571
imatinib mesylate (STI571)

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

East Melbourne, Australia

Location

MeSH Terms

Conditions

Hypereosinophilic SyndromeMastocytosis, SystemicLeukemia, Myelomonocytic, ChronicDermatofibrosarcomaLeukemia, Myelomonocytic, JuvenileLung Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

EosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesMastocytosisNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMast Cell Activation DisordersImmune System DiseasesLeukemia, MyeloidLeukemiaMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosarcomaNeoplasms, Fibrous TissueSarcomaRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2004

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

AU(1)