Clinical trial · Interventional
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
NCT01082809CI-TRIAL-00014512completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Biliary Tract Adenocarcinoma | Biliary Tract Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Sunitinib
- description
- Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- 12months
Secondary outcomes (5)
- measure
- Safety profile
- timeFrame
- 12 months
- measure
- Response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥ 18 2. histologically or cytologically confirmed adenocarcinoma of biliary tract 3. unresectable or metastatic 4. ECOG performance status of 0\~2 5. measurable or evaluable lesion per RECIST criteria 6. adequate marrow, hepatic, renal and cardiac functions 7. One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months) 8. provision of a signed written informed consent Exclusion Criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. active CNS metastases not controllable with radiotherapy or corticosteroids 4. known history of hypersensitivity to study drugs
References
Publications (1)
- DERIVEDYi 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 22176869