Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Gastrointestinal Agents

Hematinics

Vitamins

Irinotecan

Paclitaxel

Gemcitabine

Leucovorin

Fluorouracil

Albumin-Bound Paclitaxel

Pancrelipase

Sotorasib

Pancreatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Folate

Vitamin B9

Patients will either receive a combination of:

Sotorasib + Liposomal Irinotecan (nal-IRI) + 5 Fluorouracil (5FU) + Leucovorin (LV)

OR

Sotorasib + Gemcitabine (GEM) + Nab-paclitaxel

\*The combination of therapy received is based on the participants prior therapy and of the discretion of their treating physician

Intervention instruction outlined in protocol

Liposomal Irinotecan (nal-IRI)

5 Fluorouracil (5FU)

Leucovorin (LV)

Gemcitabine (GEM)

Nab paclitaxel

Devalingam Mahalingam, MD

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.

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

Clinical activity will be assessed by overall response rate (ORR). ORR is defined as the percentage of patients whose best response is Complete Response (CR) plus those with Partial Response (PR) based on RECIST 1.1.

Characterize the safety and tolerability of patients receiving sotorasib combined with chemotherapy for second line treatment of pancreas cancer. Determine safety and tolerability as determined by NCI CTCAE v 5.0

Determine progression free survival (PFS) including the 6- month, 1- year, 2-year and median progression free survival. PFS is defined from the date from first dose of study drug administration (C1D1) until the date of first documentation of progressive disease by RECIST 1.1 or death from any cause, whichever comes first

Determine the Duration of Response (DOR). DOR is defined from the date of first documentation of response to treatment, to the date of first documentation of progressive disease by RECIST 1.1 or death, whichever comes first, in patients who experience a response.

Determine the Disease Control Rate (DCR). DCR is defined as the percentage of patients whose best response is complete response (CR) plus partial response (PR) plus stable disease (SD) by RECIST 1.1.

Determine Overall Survival (OS). OS is assessed from the date of registration to the study until the date of death from any cause for up to 2 years.

Amgen

Devalingam Mahalingam

Sponsor Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer	NCT05251038	Pancreatic Canc... Unresectable Pa... Metastatic Panc... KRAS P.G12C	Sotorasib Liposomal Irino... 5 Fluorouracil ... Leucovorin (LV) Gemcitabine (GE... Nab paclitaxel	18 Years -	Hoosier Cancer Research Network
Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer	NCT05251038	Pancreatic Canc... Unresectable Pa... Metastatic Panc... KRAS P.G12C	Sotorasib Liposomal Irino... 5 Fluorouracil ... Leucovorin (LV) Gemcitabine (GE... Nab paclitaxel	18 Years -	Hoosier Cancer Research Network

Spots Global Cancer Trial Database for gemcitabine (gem)