An Additional Analysis of Data From the PARADIGM Exploratory Study (NCT02394834) in Patients With Advanced/Recurrent Colorectal Cancer

Sponsor
Takeda
Study ID
NCT05030493
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • mFOLFOX6 + panitumumab combination therapy — DRUG
    oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
  • mFOLFOX6 + bevacizumab combination therapy — DRUG
    oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Study Details

The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer. In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.

Key Dates

First listed
Sep 1, 2021
Start date
Aug 31, 2021
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
787 participants (actual)

Arms

  • Arm: 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
  • Arm: 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

Overall survival (OS) [ Time Frame: Up to approximately 63 months ]

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