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

Chronic Myelomonocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171912
• Other study ID #: CSTI571BAU12
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 21, 2017
• Start date: September 2004
• Est. completion date: January 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia
• Dermatofibrosarcoma
• Hypereosinophilic Syndrome
• Leukemia
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Mastocytosis
• Systemic Mastocytosis

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	East Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy and the safety of imatinib mesylate therapy		2 years
Secondary	To evaluate the effects of imatinib on quality of life and healthcare resource use		2 years

External Links

•   Results for CSTI571BAU12 from the Novartis Clinical Trials website