Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)



Sponsor:   Mirati Therapeutics Inc.


Sommario: 
      Study 849-010 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of
      MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line
      treatment setting in patients with CRC with KRAS G12C mutation.
    




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 3




TRATTAMENTO

  
    
  
  • MRTX849
  • Cetuximab
  • mFOLFOX6 Regimen
  • FOLFIRI Regimen
    • 






OBIETTIVO PRIMARIO


  
  • Misura: Overall Survival (OS)
  • Tempo: 30 months
  • Descrizione: Defined as time from date of randomization to date of death due to any cause.
  • Misura: Progression-free Survival (PFS)
  • Tempo: 30 months
  • Descrizione: Defined as time from randomization until disease progression or death from any cause, whichever occurs first.




OBIETTIVO SECONDARIO


  
  • Misura: Adverse Events
  • Tempo: 30 months
  • Descrizione: Defined as number of patients with treatment emergent AEs.
  • Misura: Objective Response Rate (ORR)
  • Tempo: 30 months
  • Descrizione: Defined as the percent of patients documented to have a confirmed CR or PR.
  • Misura: Duration of Response (DOR)
  • Tempo: 30 months
  • Descrizione: Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
  • Misura: Patient Reported Outcomes (PROs)
  • Tempo: 30 months
  • Descrizione: To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
  • Misura: Quality of Life Assessment
  • Tempo: 30 months
  • Descrizione: To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).




CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    
        Inclusion Criteria:

          -  Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in
             tumor tissue.

          -  Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based
             chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically
             documented progression of disease on or after treatment.

        Exclusion Criteria:

          -  Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).

          -  Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).

          -  Active brain metastasis
      
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: N/A






LUOGO


  
Research Site
Lido Di Camaiore, 55041
Research Site
Candiolo, 10060
Research Site
Avellino, 81300
Research Site
Biella, 13875
Research Site
Cagliari, 9042
Research Site
Meldola, 47014
Research Site
Milano, 20162
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Pisa, 56126
Research Site
Reggio Emilia, 42100
Research Site
Roma, 00144
Research Site
Turin, 10128