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

Phase 2

Completed

• Conditions: Biliary Tract Cancer
• Interventions: Drug: Surufatinib

• Registration Number: NCT02966821
• Lead Sponsor: Hutchison Medipharma Limited

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).

Study Timeline

• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-17
• Study Start: 2017-01-03
• Primary Completion: 2018-08-17
• Study Completion: 2018-11-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surufatinib	Surufatinib	Surufatinib 300mg once-daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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	From first dose to within 30 days after the last dose	Safety parameters monitored from the first dose to within 30 days after the last dose
Objective response rate (ORR)	6 months after the last patient enrolled	Proportion of patients with a best overall CR and PR per RECIST v1.1
Disease control rate (DCR)	6 months after the last patient enrolled	Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1
Progression-free survival (PFS)	6 months after the last patient enrolled	The time from the start date of study drug until the date of objective disease progression or death
Overall survival (OS)	6 months after the last patient enrolled	The time interval between the start date of study drug and the date of death (any cause)
Duration of response (DoR)	6 months after the last patient enrolled	The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death

Trial Locations

Locations (5)

The 307th Hospital of Military Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Heilongjiang Cancer Hospital; 🇨🇳 Ha'erbin, Heilongjiang, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Tianjin medical university cancer institute&hospital; 🇨🇳 Tianjin, Tianjin, China