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This study evaluated the safety and clinical activity of Lapatinib in patients with HER2-positive advanced solid tumors that were resistant to standard therapy. Patients with measurable disease that had not responded to standard treatment were enrolled. It was a Phase 2 study 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: * Age \> 19 * Written informed consent * ECOG 0-2, * Histologically confirmed HER2-positive Refractory solid tumor(IHC 3+ alone, or IHC 2+ with FISH amplification) and/or specific sensitivity to Lapatinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. * The presence of measurable disease as defined by the Response (Evaluation Criteria in Solid Tumors (RECIST) version 1.1) * Adequate organ function Exclusion Criteria: * Uncontrolled symptomatic brain metastasis,Uncontrolled active infection * Uncontrolled systemic illness (DM, CHF, unstable angina, hypertension or arrhythmia) * Prolonged QT interval in ECG (QTc \>450 msec) * Pregnant, lactating women * Prior treatment with lapatinib,Malabsorption syndrome, any disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication * Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer