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Clinical Trials in Japan / NCT05030493
Active, not recruiting Observational

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

NCT05030493 · tracked via the Priya Life Science Japan tracker
Sponsor
Takeda
Phase
Observational
Started
2021-08-31
Last updated
2025-12-31

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

mFOLFOX6 + panitumumab combination therapy →mFOLFOX6 + bevacizumab combination therapy →

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

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

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent. 2. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis. Exclusion Criteria: Participants who are considered inappropriate for participation in this study by the research institution.

Primary outcome measure(s)

  • Overall survival (OS) — Up to approximately 63 months
    OS obtained in the main study will be stratified by the gene expression levels in tumor tissues at the baseline of the main study to evaluate the relationship between OS and gene expression. OS will be measured as the time from the date of randomization to the date of death due to any causes.
  • Progression-Free Survival (PFS) — Up to approximately 63 months
    PFS obtained in the main study will be stratified by the gene expression levels in tumor tissues at the baseline of the main study to evaluate the relationship between the PFS and gene expression. PFS is defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause.

Trial sites (1)

FacilityCityRegionStatus
Takeda selected site Tokyo Japan

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Other trials for the same condition

Early Detection of Advanced Adenomas and Colorectal Cancer Recruiting
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors Active, not recruiting
AB122 Platform Study Recruiting
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05030493 on ClinicalTrials.gov ↗ ← All trials in Japan