Phase III Study of Surufatinib in Treating Advanced Pancreatic Neuroendocrine Tumors

Summary

Participation Requirements

Description

195 patients will be randomly assigned (in 2:1 ratio) to the Surufatinib or Placebo treatment group based on interactive web response system?IWRS).The patients will receive continuous oral treatment, every 28-day treatment cycle until progression of disease occurs, intolerable toxicity or other prot...

195 patients will be randomly assigned (in 2:1 ratio) to the Surufatinib or Placebo treatment group based on interactive web response system?IWRS).The patients will receive continuous oral treatment, every 28-day treatment cycle until progression of disease occurs, intolerable toxicity or other protocol specified end-o-treatment criteria is met. The tumor should be assessed every 8 weeks (+/-3 days) within the first year and every 12 weeks (+/-3 days) after the patient has been treated for one year. A Blinded Independent Image Review Committee (BIIRC) will subsequently provide a central review of the oncologic imaging materials from the patients. An independent Data Monitoring Committee (IDMC) will be assembled to monitor safety and efficacy data, and evaluate interim analysis. If the interim analysis demonstrates overwhelming efficacy of the treatment arm with respect to PFS (primary endpoint) versus control arm, IDMC could recommend terminating and to unblinding the study and sulfatinib will be offered to the control arm patients who are still on treatment until disease progression or intolerable toxicity.

Tracking Information