Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma

A Phase II, Single-arm, Open-label, Multicenter Study to Assess the Efficacy and Safety of Surufatinib as a Second-line Treatment in Patients With Surgically Unresectable or Metastatic Biliary Tract Carcinoma

A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma

Study Overview

• Status: Completed
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: Surufatinib

Detailed Description

This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer patients without progression or death out of these 16 patients at week 16, the study will be stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients.

Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100071
      • The 307th Hospital of Military Chinese People's Liberation Army
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150040
      • Heilongjiang Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Shanghai Zhongshan Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute＆Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of written Informed Consent Form (ICF) prior to any study specific procedures
2. Aged at least 18 years
3. Histologically or cytologically confirmed advanced BTC that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC)
4. First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities
5. ECOG 0-1
6. Patients must have measurable lesions

Exclusion Criteria:

1. Anti-tumor therapy received within 4 weeks prior to initiation of study treatment
2. Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase inhibitors or monoclonal antibody
3. Liver metastases ≥50% of liver volume
4. Child-Pugh classification score of liver function> 7
5. History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks) or a thromboembolic event (including transient ischemic attack and/or stroke events) within 12 months
6. Active malignancy (except for definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 5 years
7. Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks
8. Pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surufatinib; Surufatinib 300mg once-daily	Drug: Surufatinib; Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle); Other Names: HMPL-012 and Sulfatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) rate at Week 16	Proportion of patients without PD or death at Week 16	Progression-free survival (PFS) rate at Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03	AE monitored from the first dose to within 30 days after the last dose	From first dose to within 30 days after the last dose
Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes	Safety parameters monitored from the first dose to within 30 days after the last dose	From first dose to within 30 days after the last dose
Objective response rate (ORR)	Proportion of patients with a best overall CR and PR per RECIST v1.1	6 months after the last patient enrolled
Disease control rate (DCR)	Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1	6 months after the last patient enrolled
Duration of response (DoR)	The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death	6 months after the last patient enrolled
Progression-free survival (PFS)	The time from the start date of study drug until the date of objective disease progression or death	6 months after the last patient enrolled
Overall survival (OS)	The time interval between the start date of study drug and the date of death (any cause)	6 months after the last patient enrolled

Collaborators and Investigators

• Sponsor: Hutchison Medipharma Limited
• Investigators: Principal Investigator: Jianming Xu, Prof., The 307th Hospital of Military Chinese People's Liberation Army

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): August 17, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 11, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Biliary Tract Cancer; Surufatinib; Second-line
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: 2016-012-00CH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO