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Sponsors and Collaborators: |
Helsinki University Bayer |
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Information provided by: | Helsinki University |
ClinicalTrials.gov Identifier: | NCT00117299 |
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 (Gleevec). The study participants are required to have histologically confirmed GIST with prior imatinib treatment for metastatic GIST. is administered orally 1250 mg/day. Six patients will first enter the study. If clinical benefit is obtained in >1 of 6 patients, 9 and 30 additional patients will be entered into the protocol in two stages (a maximum of 45 patients will be entered). Patients who benefit from the study treatment will be treated with PTK787/ZK222584 until treatment failure.
Condition | Intervention | Phase |
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Sarcoma |
Drug: PTK787/ZK222584 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Open-Label Study of PTK787/ZK222584 in the Treatment of Metastatic Gastrointestinal Stromal Tumors (GISTs) Resistant to Imatinib Mesylate |
Enrollment: | 45 |
Study Start Date: | September 2004 |
Study Completion Date: | January 2009 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
PTK/ZK o.d. 1250 mg p.o.
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Drug: PTK787/ZK222584
PTK787/ZK222584 is administered at the dosage of 1250 mg o.d. orally
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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 1250 mg daily. Six patients will first enter the study using a two-stage approach. If clinical benefit is obtained in >1 of 6 patients, 9 and 30 additional patients will be entered into the protocol (a maximum total number of 45 patients will be entered). Clinical benefit is defined as the occurrence of one or more of the following 3 measures: 1) objective response to PTK787 (a confirmed or unconfirmed partial response [PR] or a complete response [CR]); 2) metabolic response defined as >50% decrease in the standardized uptake value (SUV) of FDG uptake in >1 FDG-avid lesions in one or more of the patients; or 3) stabilized disease for 3 months or longer accompanied by symptomatic or performance status improvement. Medical history, current medical conditions, weight, height, and an electrocardiogram are recorded prior to the study entry. Other baseline examinations include a chest X-ray, hematologic tests, a coagulation panel, serum chemistries, urine analysis, a serum pregnancy test and a radiological assessment of the tumor. Tumor response is monitored with imaging at 4- to 8-week intervals. Hematological tests and serum chemistries are evaluated at 1- to 4-week intervals, and adverse events are collected continuously. Research blood tests are collected at the times of tumor evaluations. Dose adjustments are carried out as per the protocol. Patients who benefit from the study treatment will be treated with PTK787/ZK222584 until treatment failure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland, FIN-00029 |
Principal Investigator: | Heikki Joensuu, M.D. | Department of Oncology, Helsinki University Central Hospital |
Responsible Party: | Helsinki University central Hospital ( Heikki Joensuu ) |
Study ID Numbers: | CPTK787 A2401/300267, GIST PTK787/ZK222584 |
Study First Received: | June 30, 2005 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00117299 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
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 |
Digestive System Neoplasms Gastrointestinal Diseases Endothelial Growth Factors Protein Kinase Inhibitors Vatalanib Imatinib Neoplasms, Connective and Soft Tissue |
Malignant Mesenchymal Tumor Soft Tissue Sarcomas Digestive System Diseases Sarcoma Gastrointestinal Neoplasms Mitogens Gastrointestinal Stromal Tumors |
Digestive System Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Endothelial Growth Factors Protein Kinase Inhibitors |
Pharmacologic Actions Vatalanib Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Site Digestive System Diseases Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |