drugset / Trial / NCT03162510
Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
Phase 1
Completed
18 enrolled
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary purpose of the study is to determine the maximal tolerated dose (MTD) of Oxaliplatin in this phase I study. The secondary objectives are to determine the response rate, progression free survival, overall survival, and safety profiles. Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression.
Timeline
- Start
- 2018-06-26
- Primary completion
- 2021-06-07
- Completion
- 2022-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 30 mg | — |
| Background | Paclitaxel | Small molecule | 150 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 35 mg/m2 | Oral |