Trials / Active Not Recruiting
Active Not RecruitingNCT05030493
An Additional Analysis of Data From the PARADIGM Exploratory Study (NCT02394834) in Patients With Advanced/Recurrent Colorectal Cancer
Additional Exploratory Analysis of Biomarkers in the PARADIGM Exploratory Study in Patients With Advanced/Recurrent Colorectal Cancer
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 787 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a non-interventional study to do additional exploratory analysis of biomarkers from the PARADIGM Exploratory Study (NCT02394834), which is conducted for participants with advanced/recurrent colorectal cancer. 757 patients have enrolled in the PARADIGM Exploratory Study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-08-31
- Primary completion
- 2027-07-31
- Completion
- 2027-07-31
- First posted
- 2021-09-01
- Last updated
- 2025-12-31
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT05030493. Inclusion in this directory is not an endorsement.