IMATINIB MESYLATE IN ADVANCED LOW GRADE SOLID TUMORS EXPRESSING IMATINIB MESYLATE TARGETS - ND

• Conditions: low grade malignant tumor (ie: solitary fibrous malignant tumor,hemangioendothelioma, myoepithelioma); MedDRA version: 9.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-000688-41-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <2.5 x ULN, SGOT and
SGPT <2,5 x UNL (or <5 x ULN if hepatic metastases are present), creatinine <1.5 x ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective of the study will be to assess the antitumor activity of Imatinib mesylate 800 mg/day in<br>the treatment of advanced low-grade tumors with biomolecular or immunohistochemical evidence<br>of Imatinib mesylate targets: PDGFR&#946; and/or PDGFR&#945; and/or c-KIT.;Secondary Objective: survival, tumor response assessment through imaging;Primary end point(s): overall response rate