Clinical trial · Interventional

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

NCT00171912CI-TRIAL-00026114completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myelomonocytic Leukemia	Chronic Myelomonocytic Leukemia	ONTOLOGY_EXACT	0.98
Dermatofibrosarcoma	Dermatofibrosarcoma Protuberans	ALIAS	0.90
Hypereosinophilic Syndrome	—	UNRESOLVED	—
Systemic Mastocytosis	Systemic Mastocytosis	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
imatinib mesylate	Drug	Imatinib Mesylate	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
imatinib mesylate (STI571)
interventionNames
1. Drug: imatinib mesylate

Primary outcomes (1)

measure
To assess the efficacy and the safety of imatinib mesylate therapy
timeFrame
2 years

Secondary outcomes (1)

measure
To evaluate the effects of imatinib on quality of life and healthcare resource use
timeFrame
2 years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Sep 1, 2004
Primary completion: Jan 1, 2012
Completion: Jan 1, 2012
First posted: Sep 15, 2005
Last update posted: Feb 23, 2017
Enrollment: 38 (actual)
Lead sponsor: Novartis Pharmaceuticals INDUSTRY
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.

Data updated 22 days agoSource updated Feb 23, 2017source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Australia	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.