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

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966821
• Other study ID #: 2016-012-00CH1
• Status: Completed
• Phase: Phase 2
• Start date: January 3, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2019
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 30, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

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)

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The 307th Hospital of Military Chinese People's Liberation Army	Beijing	Beijing
China	Heilongjiang Cancer Hospital	Ha'erbin	Heilongjiang
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	Tianjin medical university cancer institute&hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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