Clinical trial NCT00117299 (phase 2, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: ptk787/zk222584
SMILES: ClC1=CC=C(NC2=NN=C(CC3=CC=NC=C3)C3=CC=CC=C23)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically confirmed GIST

          -  Imatinib resistance (primary resistance with progression, or progression after initial
             response). Resistance is defined as objective evidence of progression after at least 4
             weeks of treatment with imatinib.

          -  Imatinib therapy has been interrupted >7 days before study entry

          -  Metastatic disease confirmed histologically, cytologically or radiologically

          -  Presence of measurable tumor lesions as determined by RECIST criteria

          -  Age 18 years or older

          -  WHO performance status of 2 or less

          -  Blood neutrophil count (ANC) 1.5 x 10^9/L or higher

          -  Platelet count 100 x 10^9/L or higher

          -  Serum bilirubin 1.5 x ULN (upper limit of normal) or less

          -  Serum creatinine 2.0 x ULN or less

          -  Written informed consent obtained according to local guidelines

        Exclusion Criteria:

          -  Patients who have received chemotherapy less than 4 weeks prior to entry into this
             study or who have not recovered from side effects of such therapy

          -  Patients who have received a cumulative dose of doxorubicin >450 mg/m2 or epirubicin
             800 mg/m2

          -  Patients who have received immunotherapy within 2 weeks or who have not recovered from
             side effects of such therapy

          -  Patients who have received radiotherapy within 2 weeks or who have not recovered from
             side effects of such therapy

          -  Major surgery within 2 weeks prior to entry into this study or patients who have not
             recovered from side effects of such therapy

          -  Patients who have received investigational drugs within 4 weeks prior to entry into
             this study or who have not recovered from side effects of such therapy

          -  Patients who are pregnant or breast feeding, or adults of reproductive potential not
             employing an effective method of birth control

          -  Concurrent severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes,
             congestive cardiac failure, myocardial infarction within 6 months, poorly controlled
             hypertension, history of labile hypertension, history of poor compliance with
             antihypertensive regimen, chronic renal disease, or active uncontrolled infection)
             which could compromise participation in the study

          -  Acute or chronic liver disease (e.g., hepatitis, cirrhosis)

          -  Confirmed diagnosis of HIV infection

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of PTK787/ZK222584 (e.g., ulcerative disease, uncontrolled
             nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to
             swallow the capsules/tablets)

          -  Patients who are taking Coumadin (warfarin sodium); heparin is acceptable.

          -  Patients unwilling to, or unable to, comply with the protocol