Advanced Biliary Tract Adenocarcinoma
Conditions
Keywords
advanced biliary tract carcinoma, Sunitinib
Brief summary
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
Interventions
DRUGSunitinib
Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | 12months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed