Study of Surufatinib as Second-line Treatment in Patients... | NCT02966821

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

NCT02966821

Sponsor

Hutchison Medipharma Limited

Status

Completed

Last Update Posted

Feb 27, 2019Actual

Enrollment

39Actual

Phase

Phase 2

Conditions

Biliary Tract Cancer

Interventions

Surufatinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2017Actual

Primary Completion Date

Aug 17, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Nov 11, 2016

First Submission Date that Met QC Criteria

Nov 16, 2016

First Posted Date

Nov 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Feb 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surufatinib	Experimental	Surufatinib 300mg once-daily	Drug: Surufatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surufatinib	Drug	Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)	Surufatinib

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jianming Xu, Prof.	The 307th Hospital of Military Chinese People's Liberation Army	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100032	China
The 307th Hospital of Military Chinese People's Liberation Army

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases