Clinical Trial: Phase III Study of Sulfatinib in Treating Advanced Pancreatic Neuroendocrine Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Multi-center Phase III Clinical Study to Assess the Efficacy and Safety of Sulfatinib Compared to Placebo in Patients With Advanced Pancreatic Neuroendocrine Tumors

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

Detailed Summary:

195 patients will be randomly assigned (in 2:1 ratio) to the Sulfatinib 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.


Sponsor: Hutchison Medipharma Limited

Current Primary Outcome: Progression Free Survival (PFS) [ Time Frame: 7 months after the last patient enrolled ]

the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The objective response rate of the tumor (ORR) [ Time Frame: 7 months after the last patient enrolled ]
    the incidence of confirmed complete response or partial response
  • The disease control rate (DCR) [ Time Frame: 7 months after the last patient enrolled ]
    the incidence of complete response, partial response and stable disease
  • Duration of Response (DoR) [ Time Frame: 7 months after the last patient enrolled ]
    the duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded
  • Time to Response (TTR) [ Time Frame: 7 months after the last patient enrolled ]
    the period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
  • Overall survival (OS) [ Time Frame: 7 months after the last patient enrolled ]
    the time from the date of randomization to the date of death (all causes)
  • •adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 [ Time Frame: From first dose to within 30 days after the last dose ]
    The safety and tolerability of sulfatinib will be evaluated based on adverse events data. Other safety parameters include physical examination, vital signs, laboratory test results (i.e., hematology, chemistry panel, and urinalysis), 12-lead electrocardiogram, and ultrasonic cardiogram.


Original Secondary Outcome: Same as current

Information By: Hutchison Medipharma Limited

Dates:
Date Received: October 26, 2015
Date Started: December 2015
Date Completion: September 2018
Last Updated: April 26, 2016
Last Verified: April 2016