Nexavar into Phase III for thyroid cancer
Clinical News | October 27, 2009
Bayer HealthCare and its partner Onyx Pharmaceuticals have started enrolling patients into an international Phase III trial of Nexavar (sorafenib), the oral oncology product already widely approved for the treatment of liver and advanced kidney cancer, in thyroid cancer that is not responding to other treatment.
The multi-centre, randomised, placebo-controlled DECISION (stuDy of sorafEnib in loCally advanced or metastatic patientS with radioactive iodine-refractory thrOid caNcer) trial will recruit some 400 patients in the US, Europe, Asia and Japan with differentiated thyroid cancer (papillary, follicular and Hurthle cell) who meet the aforementioned criteria and have not received any prior systemic therapy.
The trial participants will be randomised to 400mg of oral Nexavar twice daily or placebo. They will continue on treatment until the point of disease progression, toxicity, non-compliance or withdrawal of consent. The primary endpoint for the DECISION trial will be progression-free survival as defined by the international RECIST (Response Evaluation Criteria In Solid Tumours) criteria.
Secondary endpoints will include overall survival, time to progression and response rate, while safety and tolerability will also be assessed in the two treatment groups.
Updated results from a single-institution, investigator-sponsored Phase II open-label study of Nexavar 400mg in 56 patients with metastatic, iodine-refractory thyroid cancer were presented at the American Society of Clinical Oncology annual meeting in Florida last May/June. They showed that in 50 evaluable patients, 18 or 36% had a partial response to Nexavar according to the RECIST criteria.
Updated survival results for the first 30 patients enrolled into this study demonstrated that, across all histologies, median progression-free survival on Nexavar was 63 weeks and overall survival was 140 weeks, Bayer reported.
At present there are limited treatment options for people with thyroid cancer, particularly those who fail to respond to surgery or radiotherapy, the company noted. Each year sees more than 140,000 new cases of the disease and over 35,000 deaths from it worldwide.
Thyroid cancer is one of the few cancers with an increased incidence over the last several years, Bayer pointed out. It is the sixth most common cancer in women and around three times as many women as men develop thyroid cancer.
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