ARTICLE | Clinical News

Zactima vandetanib: Phase II data

September 20, 2010 7:00 AM UTC

In the double-blind Phase II ZACTHYF trial in 145 patients who failed treatment with or were unsuitable for treatment with radioiodine therapy, once-daily 300 mg oral Zactima met the primary endpoint of significantly improving PFS vs. placebo (11 vs. 5.8 months, p=0.008). Zactima missed the secondary endpoints of significantly improving ORR (8.3% vs. 5.5%) and DCR at 6 months (56.9% vs. 42.5%) vs. placebo. There was no significant difference in OS between treatment groups (p=0.8), but AstraZeneca said the data were immature at the time of cut-off and a final OS analysis will be performed when 50% of subjects have died. Data were presented at the International Thyroid meeting in Paris. ...