NCT05251038

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

A Phase Ib/II Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of KRAS p. G12C Mutated Advanced Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Devalingam Mahalingam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Unresectable Pancreatic Cancer
• Metastatic Pancreatic Cancer
• KRAS P.G12C

Interventions

Type	Name	Description
DRUG	Sotorasib	Intervention instruction outlined in protocol
DRUG	Liposomal Irinotecan (nal-IRI)	Intervention instruction outlined in protocol
DRUG	5 Fluorouracil (5FU)	Per standard of care
DRUG	Leucovorin (LV)	Per standard of care
DRUG	Gemcitabine (GEM)	Per standard of care
DRUG	Nab paclitaxel	Per standard of care

Timeline

• Start date: 2022-09-13
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2022-02-22
• Last updated: 2023-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study