Advanced Biliary Tract AdenocarcinomaPhase 2NCT01082809
Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma
A Phase 2 study testing Sunitinib in people with Advanced Biliary Tract Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Tract Adenocarcinoma
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Feb 2012
- 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
- age ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract
- unresectable or metastatic
- ECOG performance status of 0~2
- measurable or evaluable lesion per RECIST criteria
- adequate marrow, hepatic, renal and cardiac functions
- One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
- provision of a signed written informed consent
Who cannot join
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
Read the detailed description
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study
- Conditions
- Advanced Biliary Tract Adenocarcinoma
- Being tested
- Sunitinib
- Keywords
- advanced biliary tract carcinoma, Sunitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | No intervention | Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: 12months
Secondary outcomes (5)
Safety profile
Measured: 12 months
Response rate
Measured: 12 months
Duration of response
Measured: 12 months
Overall survival
Measured: 12 months
Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Biliary Tract AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yeong Lim, Samsung Medical Center
- Investigators
- Ho yeong Lim, M.D,Ph.D, Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082809
- Sponsor's protocol ID
- 2009-02-025
- Status last verified
- May 2014
- First submitted
- 7 Jan 2010
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Yi JH, Thongprasert S, Lee J, Doval DC, Park SH, Park JO, Park YS, Kang WK, Lim HY. A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: a multicentre, multinational study. Eur J Cancer. 2012 Jan;48(2):196-201. doi: 10.1016/j.ejca.2011.11.017. Epub 2011 Dec 14.
PubMed 22176869
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study
- ClinicalTrials.gov ID
- NCT01082809
- Acronym / sponsor ID
- 2009-02-025
- Conditions
- Advanced Biliary Tract Adenocarcinoma
- Keywords
- advanced biliary tract carcinoma, Sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Mar 2010 (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.
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
Detailed description
Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | No intervention | Drug: SunitinibSunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract
- unresectable or metastatic
- ECOG performance status of 0~2
- measurable or evaluable lesion per RECIST criteria
Key exclusion criteria (4 listed)
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids
- known history of hypersensitivity to study drugs
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 |
|---|---|---|
| SunitinibSunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle | Drug | Sunitinib |
Primary outcome
Time to progression
Time frame: 12months
5 secondary outcomes
Safety profile
Time frame: 12 months
Response rate
Time frame: 12 months
Duration of response
Time frame: 12 months
Overall survival
Time frame: 12 months
Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations
Time frame: 12 months
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 14 May 2014.
- Derived from this study: PubMed 22176869Yi JH, Thongprasert S, Lee J, Doval DC, Park SH, Park JO, Park YS, Kang WK, Lim HY. A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: a multicentre, multinational study. Eur J Cancer. 2012 Jan;48(2):196-201. doi: 10.1016/j.ejca.2011.11.017. Epub 2011 Dec 14.
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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.
Ho yeong Lim, M.D,Ph.D principal investigator
Samsung Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Advanced Biliary Tract Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
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 8 inclusion and 4 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Time to progression (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01082809, which also lists 1 linked publication.
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 14 May 2014.