Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT02588170|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Surufatinib Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||273 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||December 7, 2015|
|Actual Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||September 2020|
Surufatinib 300 mg, orally, once daily (QD)
Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
Placebo Comparator: Placebo
Placebo 300 mg, orally, once daily (QD)
Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
- Progression Free Survival (PFS) [ Time Frame: 9 months after the last patient enrolled ]the duration between the randomization date and the first disease progression (PD) or death (whichever comes first).
- The objective response rate of the tumor (ORR) [ Time Frame: 9 months after the last patient enrolled ]the incidence of confirmed complete response or partial response
- The disease control rate (DCR) [ Time Frame: 9 months after the last patient enrolled ]the incidence of complete response, partial response and stable disease
- Duration of Response (DoR) [ Time Frame: 9 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: 9 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 [ Time Frame: 9 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 Surufatinib 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588170
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100032|
|the 307 Hospital of People's Liberation Army|
|Beijing, Beijing, China, 100071|
|Beijing Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|West China Hospital, Sichuan University|
|Chengdu, Sichuan, China, 610047|
|Study Director:||Jing Li, MD||Hutchison Medi Pharma|