Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have begun enrolling patients for an international Phase III trial to evaluate Nexavar (sorafenib) for the treatment of patients with thyroid cancer.
This Phase III trial, will examine the efficacy of Nexavar for patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer based on the positive results from Phase II clinical trials.
Bayer HealthCare Pharmaceuticals Nexavar clinical development vice-president Dimitris Volioti said that the trials recognised an unmet need.
“Patients with thyroid cancer who failed to respond to surgical or radiotherapies, have limited treatment options to help them manage their disease,” said Voliotis.
The Phase III DECISION (study of sorafenib in locally advanced or metastatic patients with radioactive iodine refractory thyroid cancer) trial will enrol 400 patients in the US, Europe, Asia and Japan for the randomised, placebo-controlled study.
The primary endpoint of the study is progression-free survival as defined by response evaluation criteria in solid tumors (RECIST). Secondary endpoints include overall survival, time to progression and response rate.
