Biliary Tract CancerPhase 2NCT02966821
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
A Phase 2 study testing Surufatinib in people with Biliary Tract Cancer, run by Hutchison Medipharma Limited at 5 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Surufatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesChina
- Study dates
- 3 Jan 2017to 30 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
The 307th Hospital of Military Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071
Heilongjiang Cancer Hospital
Harbin, Heilongjiang, 150040
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, 300060
About this study
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
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
Read the 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).
- Conditions
- Biliary Tract Cancer
- Being tested
- Surufatinib
- Keywords
- Surufatinib, Biliary Tract Cancer, Second-line
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Also called HMPL-012 and Sulfatinib
Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib | Experimental | Surufatinib 300mg once-daily Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate at Week 16
Proportion of patients without PD or death at Week 16
Measured: 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
AE monitored from the first dose to within 30 days after the last dose
Measured: 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
Safety parameters monitored from the first dose to within 30 days after the last dose
Measured: From first dose to within 30 days after the last dose
Objective response rate (ORR)
Proportion of patients with a best overall CR and PR per RECIST v1.1
Measured: 6 months after the last patient enrolled
Disease control rate (DCR)
Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1
Measured: 6 months after the last patient enrolled
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
Measured: 6 months after the last patient enrolled
Progression-free survival (PFS)
The time from the start date of study drug until the date of objective disease progression or death
Measured: 6 months after the last patient enrolled
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Measured: 6 months after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start3 Jan 2017
- Primary completion17 Aug 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, Prof., Principal investigator, The 307th Hospital of Military Chinese People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966821
- Sponsor's protocol ID
- 2016-012-00CH1
- Status last verified
- Feb 2019
- First submitted
- 11 Nov 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02966821
- Acronym / sponsor ID
- 2016-012-00CH1
- Conditions
- Biliary Tract Cancer
- Keywords
- Surufatinib, Biliary Tract Cancer, Second-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib | Experimental | Drug: SurufatinibSurufatinib 300mg once-daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurufatinibAlso: HMPL-012 and SulfatinibPatients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle) | Drug | Surufatinib |
Primary outcome
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
7 secondary outcomes
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
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
Objective response rate (ORR)
Time frame: 6 months after the last patient enrolled
Disease control rate (DCR)
Time frame: 6 months after the last patient enrolled
Duration of response (DoR)
Time frame: 6 months after the last patient enrolled
Progression-free survival (PFS)
Time frame: 6 months after the last patient enrolled
Overall survival (OS)
Time frame: 6 months after the last patient enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianming Xu, Prof. principal investigator
The 307th Hospital of Military Chinese People's Liberation Army
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib in people with Biliary Tract Cancer, run by Hutchison Medipharma Limited at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rate at Week 16 (time frame: Progression-free survival (PFS) rate at Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.