- Histological diagnosis of DT or CDS.
- Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα
PDGFRβ activation and/or presence of PDGFα or PDGFβ)
- Measurable or evaluable disease
- Surgical resection of local disease unfeasible radically (or unaccepted by the
patient, or amenable to become less demolitive, or easier, or likely more feasible,
after cytoreduction) and/or metastatic disease.
- ECOG Performance status 0, 1, 2 or 3
- Adequate bone marrow, liver and renal function
- Female patients of child-bearing potential must have negative pregnancy test.
- Male and female patients of reproductive potential must agree to employ an effective
method of birth control throughout the study.
- Written, voluntary, informed consent.
- Previous treatment with any other investigational or not investigational agents
within 28 days of first day of study drug dosing
- Other primary malignancy with <5 years clinically assessed disease-free interval,
except basal cell skin cancer or cervical carcinoma in situ.
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic
renal disease, or active uncontrolled infection)
- Known brain metastasis.
- Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Known diagnosis of human immunodeficiency virus (HIV) infection.
- Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on
- Major surgery within 2 weeks prior to study entry.
- Expected non-compliance to medical regimens (e.g. psychiatric diseases).