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

NCT02966821 | Completed Phase 2

• 1 other identifier: 2016-012-00CH1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

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

Conditions

Biliary Tract Cancer

Keywords

Surufatinib; Biliary Tract Cancer; Second-line

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03

  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

  From first dose to within 30 days after the last dose

• Objective response rate (ORR)

  6 months after the last patient enrolled

• Disease control rate (DCR)

  6 months after the last patient enrolled

• Duration of response (DoR)

  6 months after the last patient enrolled

Study Arms (1)

Surufatinib

EXPERIMENTAL

Surufatinib 300mg once-daily

Drug: Surufatinib

Interventions

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)

Also known as: HMPL-012 and Sulfatinib

Surufatinib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (5)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

The 307th Hospital of Military Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

Location

Heilongjiang Cancer Hospital

Harbin, Heilongjiang, 150040, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin medical university cancer institute&hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Jianming Xu, Prof.

  The 307th Hospital of Military Chinese People's Liberation Army

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 17, 2016
• Study Start: January 3, 2017
• Primary Completion: August 17, 2018
• Study Completion: November 30, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)