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Phase Ib/II Study of Sulfatinib in Treating Advanced 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267967
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE October 20, 2014
Last Update Posted Date November 12, 2018
Actual Study Start Date  ICMJE October 31, 2014
Actual Primary Completion Date August 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Incidence and severity of AE/SAEs [ Time Frame: from day 1 of first dosing to 30 days after permanent discontinuation of Sulfatinib ]
the safety of Sulfatinib
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
safety [ Time Frame: from day 1 of first dosing to 30 days after permanent discontinuation of Sulfatinib ]
Incidence and severity of AE/SAEs
Change History Complete list of historical versions of study NCT02267967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors
Official Title  ICMJE A Multi-Center, Open-Label, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Sufatinib in Treating Advanced Neuroendocrine Tumors
Brief Summary a multicenter, open-label phase Ib study to determine the safety, tolerability and preliminary efficacy of Sulfatinib 300 mg once a day in treating advanced neuroendocrine tumors
Detailed Description The study population is patients with low- or intermediate-grade (G1 or G2) advanced NET who have failed in standard treatment or are unable to receive standard treatment.Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. Investigators will evaluate the clinical tumor response to Sulfatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Sulfatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Sulfatinib with the agreement of the sponsor.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: Sulfatinib
Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.
Other Names:
  • HMPL-012
  • Surufatinib
Study Arms  ICMJE Experimental: Sulfatinib
Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.
Intervention: Drug: Sulfatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
81
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2014)
30
Actual Study Completion Date  ICMJE August 23, 2017
Actual Primary Completion Date August 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Fully understand the study and voluntarily sign the informed consent form;
  2. Be at least 18 years old;
  3. Have a confirmed histological or cytological diagnosis of low- or intermediate-grade advanced NETs (unresectable or metastatic), for which standard treatment has failed or cannot be received. The NETs must meet the following criteria: (a) be GEP-NETs or NETs with the primary lesion located in tissue other than the lung or thymus (including unknown primary lesion location), with a mitotic count of ≤ 20/10 High Power Field [HPF] and a Ki67 index of ≤ 20%; or (b) be NETs of the lung or thymus (carcinoid) with a mitotic count of ≤ 10/10 High Power Field [HPF])
  4. Have measurable lesions (according to RECIST 1.1);
  5. Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale;
  6. Have expected survival of more than 12 weeks;
  7. Female patients with reproductive potential must agree to use an effective contraceptive method, for example, double-barrier device, condom, oral or injection birth control medication or intrauterine device, during the study and for 90 days after study completion.

Exclusion Criteria:

  1. Absolute neutrophil count (ANC) of < 1.5×109/L, or platelet count of < 100 ×109/L, or hemoglobin < 9 g/dL;
  2. Serum total bilirubin > 1.5 times the upper limit of normal (ULN);
  3. ALT, AST or ALP > 2.5 ULN without hepatic metastases or ALT, AST or ALP > 5 ULN with hepatic metastases
  4. Clinically significant serum potassium (regardless of potassium agent supplementation); serum calcium (ionic or binding to albumin post-adjusted) or clinically significant abnormal serum magnesium (regardless of magnesium agent supplementation);
  5. Serum creatinine > 1.5 ULN (with the exception of CCR ≥ 60 ml/min based on 24-hour urine collection);
  6. Urine protein > 2+, or 24-hour urine protein quantity >1 gram;
  7. Uncontrolled hypertension, defined as: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90mmHg;
  8. International Normalized Ratio (INR) > 1.5 ULN or activated partial thromboplastin time (aPTT) > 1.5 ULN. INR is only for patients not receiving anticoagulant therapy;
  9. History or presence of digestive tract diseases, including active gastric/duodenal ulcer or ulcerative colitis, or active hemorrhage of an unresected gastrointestinal tumor, or an evaluation by investigators of having any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation;
  10. History or presence of serious hemorrhage (> 30 ml within 3 months), hemoptysis (> 5 ml fresh blood within 4 weeks) or a thromboembolic event (including transient ischemic attack) within 12 months;
  11. Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrolment, severe/unstable angina pectoris or coronary artery bypass grafting, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment or left ventricular ejection fraction (LVEF) < 50%;
  12. Other malignancies within the previous 5 years, with the exception of basal cell carcinoma, squamous-cell carcinoma post radical resection, or cervical carcinoma in situ;
  13. Anti-tumor therapies within 4 weeks prior to the initiation of investigational treatment, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
  14. Palliative radiotherapy for a bone metastasis lesion within 2 weeks prior to the initiation of investigational treatment;
  15. Surgery prior to enrolment within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;
  16. Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss);
  17. Clinically significant active infection;
  18. Human immunodeficiency virus (HIV) infection;
  19. History of clinically significant hepatic diseases, including viral hepatitis, (Hepatitis B carriers with active HBV infection, i.e., HBV DNA positive [>1×104/ml]; Hepatitis C virus infection with HBV RNA positive [>1×103/ml]); or other types of hepatitis, and liver cirrhosis.
  20. Women who are pregnant or lactating;
  21. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of disease stability of longer than 14 days;
  22. Inability to orally take medicine, dysphagia or an active gastric ulcer resulting from previous surgery or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
  23. Receive investigational treatment in another clinical study within the 4 weeks prior to enrolment;
  24. Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at high risk.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02267967
Other Study ID Numbers  ICMJE 2014-012-00CH1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hutchison Medipharma Limited
Study Sponsor  ICMJE Hutchison Medipharma Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jing Li, MD Hutchison Medi Pharma
PRS Account Hutchison Medipharma Limited
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP