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

Recruiting in Palo Alto (17 mi)

Overseen byDevalingam Mahalingam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Devalingam Mahalingam

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Devalingam Mahalingam, MD

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

Inclusion Criteria

ECOG Performance Status of 0-1 within 14 days prior to registration.

Histological or cytological confirmation of pancreatic cancer per AJCC, 8th edition.

Unresectable or metastatic pancreatic cancer.

See 7 more

Treatment Details

Interventions

5 Fluorouracil (5FU) (Chemotherapy)
Gemcitabine (GEM) (Chemotherapy)
Leucovorin (LV) (Chemotherapy)
Liposomal Irinotecan (nal-IRI) (Chemotherapy)
Nab paclitaxel (Chemotherapy)
Sotorasib (Targeted Therapy)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Experimental GroupExperimental Treatment6 Interventions

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