Alderley Park, England, November 16 (ots/PRNewswire)
- First Patient Enrolled in Phase III International Randomised,
Double-Blind, Placebo-Controlled Study of Vandetanib for Non-Small
Cell Lung Cancer (NSCLC) After Failure of EGFR TKI Therapy
AstraZeneca today announced the start of enrolment into a new
Phase III study of the novel once-daily oral anti-cancer drug
vandetanib (ZACTIMA(TM), ZD6474) as third/fourth line treatment for
patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) who have progressed following EGFR TKI therapy. The
study - Study 44 - will be conducted at 208 centres across 23
countries worldwide, and is expected to enrol over 930 patients.
Study 44 will evaluate overall survival with vandetanib 300mg plus
best supportive care (BSC) compared with placebo plus BSC in patients
with advanced NSCLC, who have previously received treatment with
chemotherapy and an epidermal growth factor receptor tyrosine kinase
inhibitor (EGFR TKI). The study will also assess progression free
survival, objective response rate, disease control rate, duration of
response, effect on disease related symptoms, and safety and
tolerability of vandetanib.
Study 44 Principal Investigator Dr. Jin Soo Lee, National Cancer
Centre, Gyeonggi, Korea, commented, "There are currently very limited
treatment options available for patients after their cancer has
progressed on second line treatment. Phase II studies have
demonstrated promising anti-tumour efficacy with vandetanib in lung
cancer, and Study 44 will now investigate if this multi-targeted
agent can improve outcomes for patients."
Study 44 forms part of an extensive ongoing clinical development
programme of vandetanib in NSCLC and is the third Phase III study for
vandetanib in NSCLC to have begun patient enrolment this year. Other
- Study 57 - an international randomised, 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 32 - an international randomised, double-blind study,
comparing docetaxel alone versus treatment with vandetanib 100mg in
combination with docetaxel in patients with locally advanced or
metastatic NSCLC after failure of first-line treatment.
Vandetanib (ZACTIMA(TM), ZD6474)
Vandetanib works by inhibiting both the development of the
tumour's blood supply through inhibition of VEGFR (anti-angiogenesis)
and the growth and survival of the tumour itself through inhibition
of EGFR. It also inhibits RET kinase, an important growth factor in
certain types of thyroid cancer. Vandetanib has shown promising
anti-tumour activity in NSCLC when used alone and in combination with
docetaxel in Phase II trials., Vandetanib 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 this indication. Vandetanib is currently in clinical
development in a range of tumours.
ZACTIMA(TM) is a trademark of the AstraZeneca group of companies.
Notes to Editors
- Over 1.35 million new cases of lung cancer are diagnosed every
year and nearly 1.2 million people die as a result of this
devastating disease - more than breast, colon and prostate cancer
- If lung cancer is detected at early stages, before it has spread
to other organs or lymph nodes, around half of patients can survive
for five years or more. However, few lung cancers are found at this
early stage and it is normally diagnosed at the advanced stage, when
five year survival falls to approximately 15%.
- 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 $23.95 billion and leading positions in sales of
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology
and infection products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
- For more information about AstraZeneca, please visit:
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. Natale R et al. A comparison of the antitumour efficacy of
ZD6474 and gefitinib (Iressa(TM)) in patients with NSCLC: results of
a randomized, double-blind Phase II study. Lung Cancer 2005; 49
(Suppl 2): S36.
. Herbst R et al. ZD6474 plus docetaxel in patients with
previously treated NSCLC: results of a randomized, placebo-controlled
phase II trial. Lung Cancer 2005; 49 (Suppl 2): S35.
. Wells S et al. The Use of ZACTIMA(TM) (ZD6474) in the
Treatment of Patients with Hereditary Medullary Thyroid Carcinoma.
Presented at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics, November 2005.
ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.presseportal.ch
For further information, please contact: Janet Milton-Edwards,
AstraZeneca, Tel: +44-(0)-1625-515-275, Mobile: +44-(0)-7990-640-119,
. Carrie Deverell, AstraZeneca,
Tel: +44-(0)-1625-514-77, Mobile: +44-(0)-7929-845-108,