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news.AstraZeneca has reported the commencement of a new phase III study to evaluate its investigational drug Zactima, used for patients with non-small cell lung cancer.
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The study will investigate the addition of Zactima (generic name vandetanib) to pemetrexed as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first line anticancer treatment. The first patient is expected to enter the trial in January 2007.
As its primary objective, the phase III trial will evaluate progression-free survival with Zactima 100mg plus pemetrexed 500mg/m(2) compared with pemetrexed 500mg/m(2) plus placebo in patients with advanced NSCLC, who have previously received anticancer treatment.
The study will also assess overall survival, objective response rate, disease control rate, duration of response, effect on disease related symptoms, time to deterioration of disease-related symptoms, the safety and tolerability of Zactima in combination with pemetrexed, and population pharmacokinetics of Zactima.
This study forms part of an extensive ongoing global clinical development program for Zactima in NSCLC and is the fourth phase III study in this tumor.
Zactima has shown anti-tumor activity in NSCLC when used alone and in combination with docetaxel in phase II trials. It has also shown encouraging early data in hereditary medullary thyroid cancer and has been awarded FDA and EU orphan drug status, and FDA fast track designation for its investigation in treating medullary thyroid carcinoma.