Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
Trial Parameters
Brief Summary
The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed by disease control rate (DCR).
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan) 2. Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC (cholangiocarcinoma, gallbladder cancer or ampullary carcinoma) 3. Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 5. Life expectancy is \>12 weeks 6. Adequate bone marrow function, demonstrated by: 1. Absolute neutrophil count (ANC) ≥1,500 cell/mm3 2. Platelet count ≥ 100,000 cells/mm3 3. Hemoglobin ≥ 9 g/dL 7. Adequate liver function, demonstrated by: 1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases 2. Total bilirubin ≤1.5 x ULN 3. Albumin ≥3.0 g/dL 4. International normalized ratio (INR) \<1.5 8. Adequate renal function, demonstrated by: 1. Serum creatinine ≤1.5 x ULN