AstraZeneca completes enrollment in phase III studies of cancer drug vandetanib

AstraZeneca has announced that it has completed patient enrollment in two pivotal Phase III studies for vandetanib, the company's investigational, once-daily oral anti-cancer drug, for the second-line treatment of non-small cell lung cancer (NSCLC).

The two studies – ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) and ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) – are the second and third of four ongoing studies to complete enrollment. Data from the studies are expected later this year and the broad development program is on track for a first regulatory submission in 2008.

ZODIAC is a randomized, double-blind, international, multi-center Phase III study to assess the efficacy of vandetanib 100mg once-daily plus the standard docetaxel chemotherapy versus docetaxel alone in 1,380 patients with locally advanced or metastatic NSCLC after failure of first-line anti-cancer therapy.

ZEAL is a Phase III parallel group, randomized, double-blind study evaluating vandetanib 100mg once daily plus pemetrexed 500mg/m2 (every 3 weeks) compared with placebo plus pemetrexed as second-line treatment in 510 patients with locally advanced or metastatic NSCLC who have failed first-line anti-cancer therapy.

The ZEST study, which is investigating vandetanib versus erlotinib, was the first Phase III study of vandetanib to complete enrollment in November 2007.

“NSCLC is an area of high unmet medical need, and we hope vandetanib will offer a beneficial new treatment option that may improve the lives of people with lung cancer,” said Dr. Peter Langmuir, Medical Science Director at AstraZeneca.

ZODIAC and ZEAL are part of a broad Phase III clinical trial program designed to gain an understanding of how vandetanib may benefit people with lung cancer.

The other studies are:

• ZEST (vandetanib versus erlotinib) enrollment is complete; and
• ZEPHYR (vandetanib + best supportive care (BSC) versus BSC).

The ZEPHYR study is currently recruiting patients.

The Phase III program in NSCLC follows results from two Phase II trials where vandetanib was studied either alone or in combination with standard chemotherapy (docetaxel). Vandetanib is also being evaluated as a treatment option in medullary thyroid cancer and has been awarded Food and Drug Administration (FDA) orphan drug status and fast track designation for this tumor type.

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