Experimental Group for KRAS Mutation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
KRAS Mutation+3 MoreSotorasib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new cancer drug, sotorasib, to see if it is safe and effective when combined with standard chemotherapy for treating pancreatic cancer that has progressed after first-line treatment.

Eligible Conditions
  • KRAS Mutation
  • Unresectable Pancreatic Cancer
  • Pancreatic Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 2 years

2 months
Assess Adverse Events
2 years
Disease Control Rate (DCR)
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
Year 2
Progression Free Survival (PFS)

Trial Safety

Trial Design

1 Treatment Group

Experimental Group
1 of 1

Experimental Treatment

59 Total Participants · 1 Treatment Group

Primary Treatment: Experimental Group · No Placebo Group · Phase 1 & 2

Experimental GroupExperimental Group · 6 Interventions: Sotorasib, 5 Fluorouracil (5FU), Liposomal Irinotecan (nal-IRI), Gemcitabine (GEM), Nab paclitaxel, Leucovorin (LV) · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
2022
Completed Phase 1
~340
Leucovorin (LV)
2003
Completed Phase 3
~2070

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

AmgenIndustry Sponsor
1,296 Previous Clinical Trials
1,328,558 Total Patients Enrolled
Devalingam MahalingamLead Sponsor
1 Previous Clinical Trials
Devalingam Mahalingam, MDPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
2 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Pancreatic cancer must be confirmed by histological or cytological examination.
You have KRAS p.G12C mutation by CLIA certified molecular testing of tumor biopsy or blood based circulating tumor DNA.
Hemoglobin (Hgb) ≥ 9 g/dL; Transfusion permitted within 1 week.