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

Primary Purpose

Biliary Tract Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Surufatinib
Sponsored by
Hutchison Medipharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Surufatinib, Biliary Tract Cancer, Second-line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital
  • The 307th Hospital of Military Chinese People's Liberation Army
  • Heilongjiang Cancer Hospital
  • Shanghai Zhongshan Hospital
  • Tianjin medical university cancer institute&hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surufatinib

Arm Description

Surufatinib 300mg once-daily

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) rate at Week 16
Proportion of patients without PD or death at Week 16

Secondary Outcome Measures

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
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
Objective response rate (ORR)
Proportion of patients with a best overall CR and PR per RECIST v1.1
Disease control rate (DCR)
Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1
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
Progression-free survival (PFS)
The time from the start date of study drug until the date of objective disease progression or death
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)

Full Information

First Posted
November 11, 2016
Last Updated
February 26, 2019
Sponsor
Hutchison Medipharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02966821
Brief Title
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
Surufatinib, Biliary Tract Cancer, Second-line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surufatinib
Arm Type
Experimental
Arm Description
Surufatinib 300mg once-daily
Intervention Type
Drug
Intervention Name(s)
Surufatinib
Other Intervention Name(s)
HMPL-012 and Sulfatinib
Intervention Description
Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) rate at Week 16
Description
Proportion of patients without PD or death at Week 16
Time Frame
Progression-free survival (PFS) rate at Week 16
Secondary Outcome Measure Information:
Title
Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
Description
AE monitored from the first dose to within 30 days after the last dose
Time Frame
From first dose to within 30 days after the last dose
Title
Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes
Description
Safety parameters monitored from the first dose to within 30 days after the last dose
Time Frame
From first dose to within 30 days after the last dose
Title
Objective response rate (ORR)
Description
Proportion of patients with a best overall CR and PR per RECIST v1.1
Time Frame
6 months after the last patient enrolled
Title
Disease control rate (DCR)
Description
Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1
Time Frame
6 months after the last patient enrolled
Title
Duration of response (DoR)
Description
The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death
Time Frame
6 months after the last patient enrolled
Title
Progression-free survival (PFS)
Description
The time from the start date of study drug until the date of objective disease progression or death
Time Frame
6 months after the last patient enrolled
Title
Overall survival (OS)
Description
The time interval between the start date of study drug and the date of death (any cause)
Time Frame
6 months after the last patient enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written Informed Consent Form (ICF) prior to any study specific procedures Aged at least 18 years Histologically or cytologically confirmed advanced BTC that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC) First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities ECOG 0-1 Patients must have measurable lesions Exclusion Criteria: Anti-tumor therapy received within 4 weeks prior to initiation of study treatment Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase inhibitors or monoclonal antibody Liver metastases ≥50% of liver volume Child-Pugh classification score of liver function> 7 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 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 Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks Pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, Prof.
Organizational Affiliation
The 307th Hospital of Military Chinese People's Liberation Army
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The 307th Hospital of Military Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Heilongjiang Cancer Hospital
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Tianjin medical university cancer institute&hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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