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Completed

NCT Number: NCT02966821

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: HMPL-012 and Sulfatinib

Primary outcomes

  1. Progression-free survival (PFS) rate at Week 16

    Time frame: Progression-free survival (PFS) rate at Week 16

    Proportion of patients without PD or death at Week 16

Secondary outcomes

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

    Time frame: 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

  2. Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes

    Time frame: 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

  3. Objective response rate (ORR)

    Time frame: 6 months after the last patient enrolled

    Proportion of patients with a best overall CR and PR per RECIST v1.1

  4. Disease control rate (DCR)

    Time frame: 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

  5. Duration of response (DoR)

    Time frame: 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

  6. Progression-free survival (PFS)

    Time frame: 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

  7. Overall survival (OS)

    Time frame: 6 months after the last patient enrolled

    The time interval between the start date of study drug and the date of death (any cause)

Sponsors and collaborators

Lead sponsor

Hutchison Medipharma Limited

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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