Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With A
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).
| Condition(s) | Biliary Tract Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | InnoPharmax Inc. |
| Locations | Kaohsiung City, Taiwan; Taichung, Taiwan; Taipei, Taiwan; Taipei, Taiwan; Taipei, Taiwan |
| Start date | 2022-03-29 |
| NCT ID | NCT05065957 |
| Official listing | https://clinicaltrials.gov/study/NCT05065957 |