Status:
COMPLETED
PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors Resistant to Imatinib
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Bayer
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates the safety and efficacy of a novel tyrosine kinase inhibitor, PTK787/ZK222584, in the treatment of GIST (gastrointestinal stromal tumor) that is resistant to imatinib mesylate (Gl...
Detailed Description
This is an open-label, phase II study of PTK787/ZK222584 designed to determine the safety and efficacy of PTK787/ZK222584 in the treatment of imatinib-resistant GIST. The PTK787/ZK222584 dose used is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00117299
Start Date
September 1 2004
End Date
January 1 2009
Last Update
May 27 2010
Active Locations (1)
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1
Helsinki University Central Hospital
Helsinki, Finland, FIN-00029