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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000016782 |
Receipt No. | R000019475 |
Scientific Title | 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 |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2020/05/21 |
Basic information | ||
Public title | 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 | |
Acronym | Exploratory analysis of biomarkers in PARADIGM study | |
Scientific Title | 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 | |
Scientific Title:Acronym | Exploratory analysis of biomarkers in PARADIGM study | |
Region |
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Condition | |||
Condition | colorectal cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | This study is exploratory analysis of biomarkers to estimate treatment effects of panitumumab and bevacizumab. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Evaluation of the relationship between overall survival (OS) of the main study and mutation of each gene in tumor samples from baseline of the main study |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | mFOLFOX6 + panitumumab | |
Interventions/Control_2 | mFOLFOX6 + bevacizumab | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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 | |||
Key exclusion criteria | (1)Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study | |||
Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Takeda Pharmaceutical Company Limited | ||||||
Division name | Japan Oncology Business Unit | ||||||
Zip code | 103 - 8668 | ||||||
Address | https://www.takeda.com/jp/who-we-are/contact-us/ | ||||||
TEL | 06-6204-2111 | ||||||
protocol@paradigm-study.jp |
Public contact | |||||||
Name of contact person |
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Organization | Takeda Pharmaceutical Company Limited | ||||||
Division name | Contact for Clinical Trial Information | ||||||
Zip code | 103 - 8668 | ||||||
Address | 12-10 Nihonbashi 2-chome Chuo-ku Tokyo Japan | ||||||
TEL | 03-6226-8880 | ||||||
Homepage URL | |||||||
protocol@paradigm-study.jp |
Sponsor | |
Institute | Takeda Pharmaceutical Company Limited |
Institute | |
Department |
Funding Source | |
Organization | Takeda Pharmaceutical Company Limited |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Non-Profit Organization MINS Institutional Review Board |
Address | 5-20-9-401 Mita, Minato-ku, Tokyo |
Tel | 03-6416-1868 |
protocol@paradigm-study.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | JapicCTI-152837 |
Org. issuing International ID_1 | JAPIC |
Study ID_2 | NCT02394795 |
Org. issuing International ID_2 | clinicaltrials.gov |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019475 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |