Bayer, Onyx Initiate Patient Enrollment In Phase III Trial For Nexavar

Bayer HealthCare and Onyx Pharmaceuticals (Onyx) have initiated patient enrollment in an international phase III trial. The study is to evaluate Nexavar (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer.

Reportedly, 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. It 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.

The company said that in the trial, patients will be randomised to receive 400mg of oral Nexavar twice daily or matching placebo. Patient is expected to 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.

Todd Yancey, vice president of clinical development at Onyx, said: “Based on the positive signal generated in the phase II trial, the initiation of this phase III trial represents progress in exploring the full potential of Nexavar in a variety of treatment settings and tumor types. Building on our successful foundation of treating unresectable liver cancer and kidney cancer, we are hopeful that this phase III trial will lead to a new treatment option for patients with non-responsive thyroid cancer.”