Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC

Sponsor
Takeda
Study ID
NCT02394795
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab — DRUG
    oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
  • oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab — DRUG
    oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Study Details

The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.

Key Dates

First listed
Mar 20, 2015
Start date
May 29, 2015
Status verified
Jan 2023
Primary completion
Jan 14, 2022
Completion
Jan 14, 2022

Study Design

Enrollment
823 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group P; mFOLFOX6 + panitumumab combination therapy
    OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.
  • Active Comparator: Group B; mFOLFOX6 + bevacizumab combination therapy
    OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.

Primary Outcome Measure

OS in Participants With Left-sided Tumors [ Time Frame: Up to approximately 60 months ]

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