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This study examines the drug bosutinib (SKI-606) in patients with advanced or recurrent malignant solid tumors for which no effective therapy is available. It enrolled patients with histologically or cytologically confirmed, measurable disease. The research was conducted in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. * Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Other inclusion applies. Exclusion Criteria: * Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered. * Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1). * Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for \>= 2 weeks before day 1). * Other exclusion applies.