Overview

Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Devalingam Mahalingam
Collaborator:
Amgen
Treatments:
Fluorouracil
Gemcitabine
Irinotecan
Leucovorin
Paclitaxel