Clinical trial NCT00171912: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: To assess the efficacy and the safety of imatinib mesylate therapy
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate the effects of imatinib on quality of life and healthcare resource use
timeFrame: 2 years
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: