Metastatic Solid Tumors. Clinical Trial
Official title:
The Possible Role of Glivec in Patients With Tumor Cells Positive for C-kit or Platelet Derived Growth Factor Receptor (PDGFR); a Multi Center Study.
This is a phase II, multi-center (Israeli), open label, non-randomized trial for every
patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases
will be investigated in tumor samples obtained at the time of diagnosis or from the time of
recurrent disease. Every patient with positive expression of either of the kinases will be
evaluated for quantitative and qualitative evidence of disease prior to entry into the
study, and if possible, no other treatment will be given concomitantly, to allow evaluation
of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of
response.
Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will
receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that
in the opinion of the investigator the patient is benefiting from treatment with Glivec, and
in the absence of any safety concern. For patients with brain tumors who are not receiving
concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is
800mg/day.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment