drugset / Trial / NCT04046887
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Phase 1
Terminated
14 enrolled
Patrick Joseph Loehrer Sr.
Indiana University · collabTaiho Oncology, Inc. · collab
NaSequentialOpen-labelTreatment
Summary
The purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC)
Timeline
- Start
- 2019-09-11
- Primary completion
- 2021-05-10
- Completion
- 2023-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 600 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | TAS-102 | Small molecule | 20 mg/m2 | Oral |
| Subject | TAS-102 | Small molecule | 25 mg/m2 | Oral |
| Subject | TAS-102 | Small molecule | 30 mg/m2 | Oral |