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Spots Global Cancer Trial Database for Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors

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Trial Identification

Brief Title: Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors

Official Title: 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

Study ID: NCT02588170

Interventions

Surufatinib
Placebo

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Peking Union Medical College Hospital, Beijing, Beijing, China

the 307 Hospital of People's Liberation Army, Beijing, Beijing, China

Beijing Cancer Hospital, Beijing, Beijing, China

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Contact Details

Name: Songhua Fan, MD

Affiliation: Hutchison Medi Pharma

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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