Randomized, placebo-controlled phase II study of vandetanib plus docetaxel in previously treated non-small-cell lung cancer
作者： John V Heymach , Bruce E Johnson , Diane Prager , Edit Csada , Jaromír Roubec
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摘要: Purpose Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor-2 and epidermal receptor kinase activity. The activity vandetanib plus docetaxel was assessed in patients with previously treated non–small-cell lung cancer (NSCLC). Patients Methods This two-part study comprised an open-label run-in phase double-blind randomized phase. Eligible had locally advanced or metastatic (stage IIIB/IV) NSCLC after failure first-line platinum-based chemotherapy. primary objective the to prolong progression-free survival (PFS) receiving (100 300 mg/d) (75 mg/m2 intravenous infusion every 21 days) versus placebo docetaxel. designed have more than 75% power detect 50% prolongation at one-sided significance level P < .20. Secondary objectives included response rate, overall survival, safety tolerability. Results In (n ...
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