Phase Ib/II Study of Sulfatinib in Treating Advanced Neuroendocrine Tumors

NCT02267967 | Completed Phase 1 DMC

• 1 other identifier: 2014-012-00CH1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 7

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

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of AE/SAEs

  the safety of Sulfatinib

  from day 1 of first dosing to 30 days after permanent discontinuation of Sulfatinib

Study Arms (1)

Sulfatinib

EXPERIMENTAL

Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.

Drug: Sulfatinib

Interventions

Sulfatinib DRUG

Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.

Also known as: HMPL-012, Surufatinib

Sulfatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the study and voluntarily sign the informed consent form;
• Be at least 18 years old;
• 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 \[HPF\])
• Have measurable lesions (according to RECIST 1.1);
• Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale;
• Have expected survival of more than 12 weeks;
• 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.

You may not qualify if:

• Absolute neutrophil count (ANC) of \< 1.5×109/L, or platelet count of \< 100 ×109/L, or hemoglobin \< 9 g/dL;
• Serum total bilirubin \> 1.5 times the upper limit of normal (ULN);
• ALT, AST or ALP \> 2.5 ULN without hepatic metastases or ALT, AST or ALP \> 5 ULN with hepatic metastases
• 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);
• Serum creatinine \> 1.5 ULN (with the exception of CCR ≥ 60 ml/min based on 24-hour urine collection);
• Urine protein \> 2+, or 24-hour urine protein quantity \>1 gram;
• Uncontrolled hypertension, defined as: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90mmHg;
• 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;
• 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;
• 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;
• 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%;
• 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;
• Anti-tumor therapies within 4 weeks prior to the initiation of investigational treatment, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
• Palliative radiotherapy for a bone metastasis lesion within 2 weeks prior to the initiation of investigational treatment;
• Surgery prior to enrolment within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (7)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

the 307 Hospital of People's Liberation Army

Beijing, Beijing Municipality, 100071, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610047, China

Location

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Jing Li, MD

  Hutchison Medi Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 20, 2014
• Study Start: October 31, 2014
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

CN (7)