Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma
Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study
1 other identifier
interventional
59
1 country
1
Brief Summary
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
March 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMay 14, 2014
May 1, 2014
2.8 years
January 7, 2010
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression
12months
Secondary Outcomes (5)
Safety profile
12 months
Response rate
12 months
Duration of response
12 months
Overall survival
12 months
Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations
12 months
Study Arms (1)
Sunitinib
NO INTERVENTIONSunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 22176869DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ho yeong Lim, M.D,Ph.D
Samsung Medical Center, Seoul, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Samsung Medical center
Study Record Dates
First Submitted
January 7, 2010
First Posted
March 9, 2010
Study Start
March 1, 2009
Primary Completion
January 1, 2012
Study Completion
February 1, 2012
Last Updated
May 14, 2014
Record last verified: 2014-05