Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Advanced Biliary Tract Adenocarcinoma

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01082809

2009-02-025

Details and patient eligibility

About

The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

Full description

Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

59 participants in 1 patient group

Sunitinib

No Intervention group

Description:

Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle

Treatment:

Drug: Sunitinib