NCT02588170

Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors

A Randomized, Double-blind, Multi-center Phase III Clinical Study to Assess the Efficacy and Safety of Surufatinib Compared to Placebo in Patients With Advanced Extrapancreatic Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the efficacy of Surufatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine tumors.

Detailed description

273 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 Surufatinib will be offered to the control arm patients who are still on treatment until disease progression or intolerable toxicity.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
OTHER	Placebo	Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle

Timeline

• Start date: 2015-12-07
• Primary completion: 2019-03-31
• Completion: 2022-07-07
• First posted: 2015-10-27
• Last updated: 2023-03-30

Locations

5 sites across 1 country: China