Vandetanib Phase Ii Trial Shows Significant Improvement Of Progression Free Survival In Patients Wit

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13th September 2010, 02:30am - Views: 795

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Vandetanib Phase II Trial Shows Significant Improvement of Progression Free Survival in Patients With

Advanced Papillary or Follicular Thyroid Cancer

PARIS, Sept. 12 /PRNewswire-AsiaNet/ --


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    AstraZeneca today announced results from a phase II study evaluating the

investigational drug vandetanib for the treatment of patients with locally

advanced or metastatic papillary or follicular thyroid cancer. This study,

ZACTHYF, showed that treatment with vandetanib significantly improved

Progression Free Survival (PFS), the primary endpoint of the study, compared

to placebo (Hazard Ratio=0.63, p=0.008). Median PFS was improved by 5 months

(11.0 months for vandetanib and 5.8 months for placebo patients). The results

of the ZACTHYF study were presented today at the International Thyroid

Congress in Paris.

    ZACTHYF is a phase II, randomised, double blind, placebo controlled,

multi-centre study, which compared oral once-daily vandetanib 300mg to

placebo in 145 patients with locally advanced or metastatic papillary or

follicular thyroid cancer who failed treatment with, or were unsuitable for,

radioiodine therapy.

    "Papillary and follicular thyroid cancer are the most common forms of

thyroid cancer and these results show evidence of vandetanib activity in

patients with advanced metastatic disease where there are few treatment

options after surgery and treatment with radioactive iodine," said Peter

Langmuir, M.D. Executive Director, Medical-Science, AstraZeneca, "This adds

to previous data which shows vandetanib to be the first therapy to

demonstrate improved efficacy vs placebo in a phase III trial in patients

with advanced medullary thyroid cancer."

    There were no significant differences observed in ZACTHYF between

vandetanib and placebo groups across the secondary efficacy endpoints of

objective response rate, disease control rate at six months and overall

survival. The safety profile of vandetanib is consistent across all thyroid

studies. The most common adverse events are diarrhoea, asthenia, fatigue,

hypertension, decreased appetite, nausea, acne, rash and QTc prolongation.

    AstraZeneca plans regulatory submissions in 2010 for the treatment of

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patients with advanced medullary thyroid cancer.

    Vandetanib is thought to work by inhibition of the vascular endothelial

growth factor (VEGF) pathway, epidermal growth factor receptor (EGFR) and

rearranged during transfection (RET) pathways.

    About AstraZeneca

    AstraZeneca is a global, innovation-driven biopharmaceutical business

with a primary focus on the discovery, development and commercialisation of

prescription medicines. As a leader in gastrointestinal, cardiovascular,

neuroscience, respiratory and inflammation, oncology and infectious disease

medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.

    SOURCE: AstraZeneca


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