drugset / Trial / NCT05065957
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
RandomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2022-03-29
- Primary completion
- 2026-07
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 800 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | D07001 | Unknown | 20 mg | Oral |
| Subject | D07001 | Unknown | 40 mg | Oral |
| Subject | D07001 | Unknown | 60 mg | Oral |
| Subject | D07001 | Unknown | 80 mg | Oral |
| Subject | D07001 | Unknown | 100 mg | Oral |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Comparator | Oxalipatin | Unknown | — | Intravenous |
| Subject | S-1 | Small molecule | 20 mg | — |
| Subject | S-1 | Small molecule | 30 mg | — |
| Subject | S-1 | Small molecule | 40 mg | — |
| Subject | S-1 | Small molecule | 50 mg | — |
| Subject | S-1 | Small molecule | 60 mg | — |
| Comparator | fluorouracil | Small molecule | — | Intravenous |