AstraZeneca today announced the commencement of a new Phase III study of its new investigational once-daily orally administered drug, vandetanib (ZACTIMA(R), ZD6474). Study 36 will investigate the addition of vandetanib to pemetrexed (Alimta(R)) as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first line anti-cancer treatment. Study 36 will be conducted across 20 countries worldwide, including 20 sites in the United States, and is expected to enroll at least 508 patients, with the first patient entering the trial in January 2007.
As its primary objective, Study 36 will evaluate progression-free survival with vandetanib 100mg plus pemetrexed 500mg/m(2) compared with pemetrexed 500mg/m(2) plus placebo in patients with advanced NSCLC, who have previously received anti-cancer 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 vandetanib in combination with pemetrexed, and population pharmacokinetics of vandetanib.
"After treatment failure with initial therapy, response rates to further treatment are low in patients with advanced non-small cell lung cancer," said Dr. Peter Langmuir, Medical Science Director for vandetanib at AstraZeneca. "The effect of combining novel targeted agents, such as vandetanib, with chemotherapy needs to be explored in order to further progress treatment options for patient benefit."
Study 36 forms part of an extensive ongoing global clinical development program for vandetanib in NSCLC and is the fourth Phase III study in this tumor; the other three studies are:
* Study 32 - a randomized, double-blind study, comparing vandetanib 100mg
in combination with docetaxel with docetaxel alone in patients with
locally advanced or metastatic NSCLC after failure of first-line
treatment
* Study 57 - a randomized, double-blind study of vandetanib 300mg
monotherapy versus erlotinib 150mg in patients with advanced NSCLC
after failure of at least one, but no more that two, prior chemotherapy
regimens
* Study 44 - a randomized, double-blind, placebo-controlled study of
vandetanib 300mg plus best supportive care (BSC) compared with placebo
plus BSC as third/fourth line treatment in patients with non-small cell
lung cancer (NSCLC) after treatment failure with chemotherapy and an
epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI)
About the Study
Male and female patients 18 years of age and older with a confirmed diagnosis of locally advanced or metastatic NSCLC and who have failed one prior chemotherapy regimen are eligible. The study is expected to enroll approximately 508 patients.
Patients and health care providers interested in learning more about the study can visit
www.clinicaltrials.gov and enter the trial's identifier code of NCT00418886 for more information. They can also call the AstraZeneca Cancer Support Network toll-free at 1-(866)-992-9276.
About Vandetanib (ZACTIMA(R), ZD6474)
ZACTIMA is an investigational drug being studied as a multitargeted compound, to evaluate its effect on the inhibition of key cell signalling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor (EGFR) and REarranged during Transfection (RET) tyrosine kinases, while tumor blood supply is targeted through inhibition of vascular endothelial growth factor receptor (VEGFR) tyrosine kinases. RET tyrosine kinase activity is an important growth driver in certain tumors.
Vandetanib has shown anti-tumor activity in NSCLC when used alone and in combination with docetaxel in Phase II trials.(1,2) It has also shown encouraging early data in hereditary medullary thyroid cancer(3) and has been awarded FDA and EU orphan drug status, and FDA fast track designation for its investigation in treating medullary thyroid carcinoma. Vandetanib is currently in clinical development in a range of tumors.
About Lung Cancer
Lung cancer is the leading cause of cancer death in the United States in both men and women, according to the American Cancer Society. The five-year relative survival rate for all stages of lung cancer is 15 percent. Survival from lung cancer has shown little improvement for more than 20 years.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
ZACTIMA(R) is a registered trademark of the AstraZeneca group of companies.
Alimta(R) is a registered trademark of Eli Lilly and Company.
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of these risks and uncertainties, please see the company's Annual Report/Form 20-F for 2005.
References
1. Natale RB et al. ZD6474 versus gefitinib in patients with advanced
NSCLC: Final results from a two-part, double-blind randomized phase II
trial. Proceedings of ASCO 2006; abstract no. 7000.
2. Heymach JV et al. A phase II trial of ZD6474 plus docetaxel in
patients with previously treated NSCLC: Follow-up results. Proceedings
of ASCO 2006; abstract no. 7016.
3. Wells S et al. A phase II trial of ZD6474 in patients with hereditary
metastatic medullary thyroid cancer. Proceedings of ASCO 2006;
abstract no. 5533.
SOURCE AstraZeneca
Katie Neff of AstraZeneca, +1-302-885-9960, or katie.neff@astrazeneca.com http://www.astrazeneca-us.com/ www.CSTADirect.com 
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发表于 2007-4-6 11:11:26
发表于 2007-4-7 18:43:51
