low grade malignant tumor (ie: solitary fibrous malignant tumor, hemangioendothelioma, myoepithelioma) MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GLIVEC*24CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: IMATINIB MESYLATO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histological diagnosis of low grade malignant tumor (ie: solitary fibrous malignant tumor, hemangioendothelioma, myoepithelioma) 2. Biomolecular or immunohistochemical evidence of overexpression/activation of any of the following Imatinib mesylate targets: PDGFRβ PDGFRα c-KIT 3. Measurable disease 4. Unfeasible radical surgical resection of local disease, or surgery unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction, and/or metastatic disease. Debulking surgery before enrolment is allowed. In this case, enrolment should occur at least one month after surgery 5. Performance status (ECOG) 0, 1, 2 or 3 6. Adequate organ function, defined as the following: total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing. 2. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study) 3. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). 4. Known brain metastasis. 5. Known diagnosis of human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective of the study will be to assess the antitumor activity of Imatinib mesylate 800 mg/day in the treatment of advanced low-grade tumors with biomolecular or immunohistochemical evidence of Imatinib mesylate targets: PDGFRβ and/or PDGFRα and/or c-KIT.;Secondary Objective: survival, tumor response assessment through imaging;Primary end point(s): overall response rate | — |
Countries
Italy
Outcome results
None listed