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ACTIVE NOT RECRUITING
NCT05030493

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

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: Additional Exploratory Analysis of Biomarkers in the PARADIGM Exploratory Study in Patients With Advanced/Recurrent Colorectal Cancer

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

OBSERVATIONAL

Enrollment

787

Start Date

2021-08-31

Completion Date

2027-07-31

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

mFOLFOX6 + panitumumab combination therapy

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

DRUG

mFOLFOX6 + bevacizumab combination therapy

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

Locations (1)

Takeda selected site

Tokyo, Japan