PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors Resistant to Imatinib
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ClinicalTrials.gov Identifier: NCT00117299 |
Recruitment Status :
Completed
First Posted : July 6, 2005
Last Update Posted : May 27, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: PTK787/ZK222584 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open-Label Study of PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors (GISTs) Resistant to Imatinib Mesylate |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | January 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: A
PTK/ZK o.d. 1250 mg p.o.
|
Drug: PTK787/ZK222584
PTK787/ZK222584 is administered at the dosage of 1250 mg o.d. orally
Other Name: vatalanib |
- Response rate [ Time Frame: 1 year ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117299
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland, FIN-00029 |
Principal Investigator: | Heikki Joensuu, M.D. | Department of Oncology, Helsinki University Central Hospital |
Responsible Party: | Heikki Joensuu, Helsinki University central Hospital |
ClinicalTrials.gov Identifier: | NCT00117299 |
Other Study ID Numbers: |
CPTK787 A2401/300267 GIST PTK787/ZK222584 |
First Posted: | July 6, 2005 Key Record Dates |
Last Update Posted: | May 27, 2010 |
Last Verified: | May 2010 |
Gastrointestinal stromal tumor GIST Sarcoma PTK787 ZK 222584 Tyrosine kinase inhibitor Tyrosine kinase VEGF |
Vascular endothelial growth factor VEGFR Vascular endothelial growth factor receptor KDR KIT c-KIT Platelet derived growth factor receptor PDGFR |
Gastrointestinal Stromal Tumors Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Sarcoma Vatalanib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |