drugset / Trial / NCT05251038
Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, non-randomized, open-label, phase Ib/II study to evaluate the safety, tolerability and efficacy of sotorasib in combination with chemotherapy for patients with advanced KRAS p.G12C mutant pancreatic cancer with progression of disease after first line treatment. There will be a safety lead in to determine the safety and tolerability of the sotorasib in combination with standard chemotherapy. A Simon two-stage design will be employed to evaluate the efficacy of sotorasib in combination with standard of care second line chemotherapy.
Timeline
- Start
- 2022-09-13
- Primary completion
- 2023-01-31
- Completion
- 2023-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sotorasib | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Irinotecan | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |