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Recruiting
Sponsor ID
20210081

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C MutationCodeBreaK 301

Sponsor ID
20210081
Clinicaltrials.gov ID
NCT06252649
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Additional Study Details

Phase
Phase 3
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
450
Additional Study Details

Protocol Summary

Primary Outcome Measures

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Timeframe: Up to Approximately 3 Years

Secondary Outcome Measures

Overall Survival (OS)

Timeframe: Up to Approximately 5 Years

Objective Response Rate (ORR) per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Objective Response (OR) per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Duration of Response (DOR) per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Disease Control Rate (DCR) per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Time to Response (TTR) per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Depth of Response per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Time to Early Tumor Shrinkage (ETS) per RECIST v1.1

Timeframe: Up to Approximately 5 Years

PFS Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

ORR Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

DOR Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

DCR Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

TTR Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Depth of Response Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Time to ETS Based on Investigator’s Assessment per RECIST v1.1

Timeframe: Up to Approximately 5 Years

Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to Approximately 5 Years

Pre-dose (Ctrough) Concentrations of Sotorasib

Timeframe: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

Maximum Plasma Concentration (Cmax) of Sotorasib

Timeframe: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

Locations

Location
Status
Contact Us
Location
Hospital Britanico de Buenos Aires
Buenos Aires, Buenos Aires, Argentina, C1280AEB
Status
Recruiting
Location
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
Status
Terminated
Location
Instituto Argentino de Diagnóstico y Tratamiento
CABA, Buenos Aires, Argentina, C1093AAS
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Flinders Medical Centre
Bedford Park, SA, Australia, 5042
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Jul 2024 - Sep 2028
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. • Central laboratory detection of KRAS p.G12C mutation. • Measurable metastatic disease per RECIST v1.1 criteria. • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. • Adequate organ function.
    Exclusion Criteria:
    • Active, untreated brain metastases. • Leptomeningeal disease • Previous treatment with a KRAS p.G12C inhibitor • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan