Bayer HealthCare AG and Onyx Pharmaceuticals, Inc today announced that the companies have begun enrolling patients in
an international phase III trial to evaluate Nexavar (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer.
This phase III trial was started based on the results from Phase II clinical trials evaluating Nexavar in patients with advanced thyroid cancer.
“Patients with thyroid cancer, particularly those who failed to respond to surgical or radiotherapies have limited treatment options to help them manage their disease,” said Dimitris Voliotis, Vice President, Clinical Development, Bayer HealthCare. “Recognizing this unmet need, we are evaluating Nexavar in this special patient population.”
Phase III Trial Design
The DECISION (study of sorafenib in locally advanced or metastatic patients with radioactive Iodine-refractory thyroid cancer) trial is an international, multicenter, randomised, placebo-controlled study that will enroll approximately 400 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular and Hurthle cell) who have received no prior systemic therapy.
Patients will be randomized to receive 400mg of oral Nexavar twice daily or matching placebo. Patients will continue on treatment until disease progression, toxicity, non-compliance or withdrawal of consent. At the time of progression, patients receiving placebo will have an option to cross over to Nexavar at the discretion of the investigator, based on the patient’s clinical status. The primary endpoint of the study is progression-free survival as defined by RECIST criteria.
Secondary endpoints include overall survival, time to progression and response rate.
The safety and tolerability of the two treatment groups will also be compared.