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 Mutation

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Amgen
Study ID
NCT06252649
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRI Regimen — DRUG
    Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
  • Sotorasib — DRUG
    Immediate-release solid dosage form administered orally.
  • Panitumumab — DRUG
    Administered via IV infusion Q2W.
  • Bevacizumab-awwb — DRUG
    Administered via IV infusion Q2W.

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.

Key Dates

Start date
Jul 17, 2024
Status verified
Jun 2026
Primary completion
Sep 25, 2028
Completion
Apr 25, 2032

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Sotorasib + Panitumumab + FOLFIRI
    Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
  • Active Comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb
    Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.

Primary Outcome Measure

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to Approximately 3 Years ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research Centers ScottsdaleChandlerArizona85224-
Providence Saint Jude Medical CenterFullertonCalifornia92835-
City of Hope National Medical CenterLong BeachCalifornia90813-
Cancer and Blood Research Center, LLCLos AlamitosCalifornia90720-
California Research InstituteLos AngelesCalifornia90027-
Norwalk HospitalNorwalkConnecticut06856-
Cancer Specialists of North Florida - SouthpointJacksonvilleFlorida32256-
D and H Cancer Research CenterMargateFlorida33063-
Mid Florida Hematology and Oncology Centers PAOrange CityFlorida32763-
Boca Raton Clinical Research Medical Center IncPlantationFlorida33322-
Georgia Cancer SpecialistsAtlantaGeorgia30342-
Insight Research InstituteChicagoIllinois60616-
Hope and Healing Cancer ServicesHinsdaleIllinois60521-
Orchard Healthcare Research IncSkokieIllinois60076-
Pikeville Medical CenterPikevilleKentucky41501-
Henry Ford Health SystemDetroitMichigan48202-
Cancer and Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Saint Louis Cancer Care West CountyBridgetonMissouri63044-
Minniti Center for Medical Oncology and HematologyMickletonNew Jersey08056-
Duke Cancer CenterDurhamNorth Carolina27710-
FirstHealth Cancer CenterPinehurstNorth Carolina28374-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Carolina Blood and Cancer CareRock HillSouth Carolina29732-
Tennessee Oncology PLLC - ChattanoogaNashvilleTennessee37203-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer and Research Centers Scottsdale· Chandler, AZProvidence Saint Jude Medical Center· Fullerton, CACity of Hope National Medical Center· Long Beach, CACancer and Blood Research Center, LLC· Los Alamitos, CACalifornia Research Institute· Los Angeles, CANorwalk Hospital· Norwalk, CT

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