An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

April 7, 2026 updated by: Takeda

An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Phase III, Randomized, Controlled Study Comparing the Efficacy and Safety of mFOLFOX6 + Bevacizumab Therapy vs. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Wild-type RAS(KRAS/NRAS) Unresectable Advanced or Recurrent Colorectal Cancer

The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan
      • Aomori, Japan
      • Chiba, Japan
      • Fukui, Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Kagoshima, Japan
      • Kochi, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Miyazaki, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Niigata, Japan
      • Okayama, Japan
      • Okinawa, Japan
      • Osaka, Japan
      • Saga, Japan
      • Saitama, Japan
      • Shizuoka, Japan
      • Tokushima, Japan
      • Toyama, Japan
      • Yamagata, Japan
    • Aichi-ken
      • Ichinomiya, Aichi-ken, Japan
      • Komaki, Aichi-ken, Japan
      • Kounan, Aichi-ken, Japan
      • Nagakute, Aichi-ken, Japan
      • Nagoya, Aichi-ken, Japan
      • Okazaki, Aichi-ken, Japan
      • Toyohashi, Aichi-ken, Japan
      • Toyokawa, Aichi-ken, Japan
      • Toyota, Aichi-ken, Japan
      • Yatomi, Aichi-ken, Japan
    • Akita
      • Daisen, Akita, Japan
    • Aomori
      • Hirosaki, Aomori, Japan
      • Misawa, Aomori, Japan
    • Chiba
      • Kashiwa, Chiba, Japan
      • Yachiyo, Chiba, Japan
    • Ehime
      • Matsuyama, Ehime, Japan
      • Tōon, Ehime, Japan
    • Fukui
      • Tsuruga, Fukui, Japan
      • Yoshida, Fukui, Japan
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
      • Koga, Fukuoka, Japan
      • Kurume, Fukuoka, Japan
      • Omuta, Fukuoka, Japan
    • Fukushima
      • Aizu-Wakamatsu, Fukushima, Japan
      • Iwaki, Fukushima, Japan
      • Kōriyama, Fukushima, Japan
      • Shirakawa, Fukushima, Japan
    • Gifu
      • Hashima, Gifu, Japan
      • Kakamigahara, Gifu, Japan
      • Minokamo, Gifu, Japan
      • Okazai, Gifu, Japan
      • Ōgaki, Gifu, Japan
    • Gunma
      • Maebashi, Gunma, Japan
      • Ōta, Gunma, Japan
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
    • Hokkaido
      • Hakodate, Hokkaido, Japan
      • Kitami, Hokkaido, Japan
      • Kushiro, Hokkaido, Japan
      • Obihiro, Hokkaido, Japan
      • Otaru, Hokkaido, Japan
      • Sapporo, Hokkaido, Japan
    • Hyōgo
      • Akashi, Hyōgo, Japan
      • Amagasaki, Hyōgo, Japan
      • Himeji, Hyōgo, Japan
      • Kobe, Hyōgo, Japan
      • Nishinomiya, Hyōgo, Japan
    • Ibaraki
      • Hitachi, Ibaraki, Japan
      • Kasama, Ibaraki, Japan
      • Ryūgasaki, Ibaraki, Japan
      • Tsuchiura, Ibaraki, Japan
      • Tsukuba, Ibaraki, Japan
    • Ishikawa-ken
      • Hakusan, Ishikawa-ken, Japan
      • Kaga, Ishikawa-ken, Japan
      • Kahoku, Ishikawa-ken, Japan
      • Kanazawa, Ishikawa-ken, Japan
      • Nanao, Ishikawa-ken, Japan
    • Iwate
      • Morioka, Iwate, Japan
    • Kagawa-ken
      • Kida, Kagawa-ken, Japan
      • Marugame, Kagawa-ken, Japan
      • Takamatsu, Kagawa-ken, Japan
    • Kanagawa
      • Fujisawa, Kanagawa, Japan
      • Hiratsuka, Kanagawa, Japan
      • Isehara, Kanagawa, Japan
      • Kamakura, Kanagawa, Japan
      • Kanazawachō, Kanagawa, Japan
      • Sagamihara, Kanagawa, Japan
      • Yokohama, Kanagawa, Japan
      • Yokosuka, Kanagawa, Japan
    • Kochi
      • Nankoku, Kochi, Japan
    • Mie-ken
      • Matsuzaka, Mie-ken, Japan
      • Tsu, Mie-ken, Japan
      • Yokkaichi, Mie-ken, Japan
    • Miyagi
      • Ishinomaki, Miyagi, Japan
      • Murata, Miyagi, Japan
      • Natori-shi, Miyagi, Japan
      • Sendai, Miyagi, Japan
      • Ōsaki, Miyagi, Japan
    • Nagano
      • Matsumoto, Nagano, Japan
      • Saku, Nagano, Japan
    • Nagasaki
      • Sasebo, Nagasaki, Japan
      • Ōmura, Nagasaki, Japan
    • Nara
      • Ikoma, Nara, Japan
      • Tenri, Nara, Japan
      • Yamatotakada, Nara, Japan
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan
    • Okinawa
      • Naha, Okinawa, Japan
      • Tomigusuku, Okinawa, Japan
      • Urasoe, Okinawa, Japan
    • Osaka
      • Hirakata, Osaka, Japan
      • Kawachi-Nagano, Osaka, Japan
      • Moriguchi, Osaka, Japan
      • Neyagawa, Osaka, Japan
      • Sayama, Osaka, Japan
      • Suita, Osaka, Japan
      • Takatsuki, Osaka, Japan
    • Saitama
      • Kawagoe, Saitama, Japan
      • Kitaadachi, Saitama, Japan
      • Koshigaya, Saitama, Japan
    • Shiga
      • Moriyama, Shiga, Japan
      • Ōtsu, Shiga, Japan
    • Shimane
      • Izumi, Shimane, Japan
      • Izumo, Shimane, Japan
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
      • Izunokuni, Shizuoka, Japan
      • Sunto, Shizuoka, Japan
    • Tochigi
      • Shimotsuga, Tochigi, Japan
      • Shimotsuke, Tochigi, Japan
      • Utsunomiya, Tochigi, Japan
    • Tokushima
      • Komatsushimachō, Tokushima, Japan
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
      • Chiyoda-ku, Tokyo, Japan
      • Chuo-ku, Tokyo, Japan
      • Itabashi-ku, Tokyo, Japan
      • Koto-ku, Tokyo, Japan
      • Machida, Tokyo, Japan
      • Minato-ku, Tokyo, Japan
      • Musashino, Tokyo, Japan
      • Shinagawa-ku, Tokyo, Japan
      • Shinjyuku-ku, Tokyo, Japan
    • Tottori
      • Yonago, Tottori, Japan
    • Toyama
      • Kurobe-shi, Toyama, Japan
      • Takaoka, Toyama, Japan
    • Yamagata
      • Sakata, Yamagata, Japan
      • Tsuruoka, Yamagata, Japan
    • Yamaguchi
      • Iwakuni, Yamaguchi, Japan
    • Yamanashi
      • Kofu, Yamanashi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study.

Description

Inclusion Criteria:

(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study

Exclusion Criteria:

(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 63 months
OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes.
Up to approximately 63 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to approximately 63 months
PFS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. 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.
Up to approximately 63 months
Response Rate (RR)
Time Frame: Approximately 12 months
RR obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. RR is defined as percentage of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.
Approximately 12 months
Duration of Response (DOR)
Time Frame: Up to approximately 63 months
DOR obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations. DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.
Up to approximately 63 months
Percentage of Participants who Proceeded to Surgical Resection
Time Frame: Up to approximately 63 month
The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations.
Up to approximately 63 month
Percentage of Participants with Early Tumor Shrinkage
Time Frame: Up to approximately 63 months
The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations.
Up to approximately 63 months
Degree of the Maximum Tumor Shrinkage (Depth of Response)
Time Frame: Up to approximately 63 months
The outcome obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study to evaluate the relationship between the efficacy endpoint and gene mutations.
Up to approximately 63 months
Evaluation of the Relationship of Each Biomarker in Plasma Free DNA and Tumor Samples at Baseline of the Main Study
Time Frame: Up to approximately 63 months
Up to approximately 63 months
Evaluation of the Relationship between Each Biomarker in Plasma Free DNA at Baseline of the Main Study, and Efficacy Endpoints
Time Frame: Up to approximately 63 months
Up to approximately 63 months
Evaluation of the Relationship between a Change in Each Biomarker in Plasma Free DNA at Baseline and the Discontinuation of the Protocol Treatment of the Main Study, and Efficacy Endpoints
Time Frame: Up to approximately 63 months
Up to approximately 63 months
Evaluation of the Relationship between a Change in Each Biomarker in Tumor Tissue at Baseline and the Discontinuation of the Protocol Treatment of the Main Study, and Efficacy Endpoints
Time Frame: Up to approximately 63 months
Up to approximately 63 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Panitumumab-4004
  • U1111-1167-3521 (Other Identifier: WHO)
  • UMIN000016782 (Registry Identifier: UMIN Clinical Trials Registry)
  • jRCT1080222785 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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