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

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ClinicalTrials.gov Identifier: NCT02966821
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Surufatinib Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surufatinib
Surufatinib 300mg once-daily
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)
Other Name: HMPL-012 and Sulfatinib




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966821


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
The 307th Hospital of Military Chinese People's Liberation Army
Beijing, Beijing, China, 100071
China, Heilongjiang
Heilongjiang Cancer Hospital
Ha'erbin, Heilongjiang, China, 150040
China, Shanghai
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200032
China, Tianjin
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Jianming Xu, Prof. The 307th Hospital of Military Chinese People's Liberation Army

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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02966821     History of Changes
Other Study ID Numbers: 2016-012-00CH1
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hutchison Medipharma Limited:
Surufatinib
Biliary Tract Cancer
Second-line

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases