Phase III Study of Sulfatinib in Treating Advanced Pancreatic Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02589821|
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Sulfatinib Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||195 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 Sulfatinib Compared to Placebo in Patients With Advanced Pancreatic Neuroendocrine Tumors|
|Actual Study Start Date :||December 7, 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2018|
Sulfatinib 300 mg, orally, once daily (QD)
Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
Other Name: •HMPL-012
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: 7 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: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589821
|Contact: Neo Li||+86 21-2067 3222||Jingli@hmplglobal.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100032|
|Contact: Chunmei Bai, Prof. email@example.com|
|Principal Investigator: Chunmei Bai, Prof.|
|the 307 Hospital of People's Liberation Army||Recruiting|
|Beijing, Beijing, China, 100071|
|Contact: Jianming XU, Prof. firstname.lastname@example.org|
|Principal Investigator: Jianming XU, Prof.|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Jie Li, Prof. email@example.com|
|Principal Investigator: Jie Li, Prof.|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Zhiwei Zhou, Prof. firstname.lastname@example.org|
|Principal Investigator: Zhiwei Zhou, Prof.|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610047|
|Contact: Zhiping Li, Prof. email@example.com|
|Principal Investigator: Zhiping Li, Prof.|
|Study Director:||Charlie Qi, MD||Hutchison Medi Pharma|