Spots Global Cancer Trial Database for Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer
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Trial Identification
Brief Title: Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer
Official Title: A Phase Ib/II Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of KRAS p. G12C Mutated Advanced Pancreatic Cancer
Study ID: NCT05251038
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwestern University, Chicago, Illinois, United States
Contact Details
Name: Devalingam Mahalingam, MD
Affiliation: Northwestern University Feinberg School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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