UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031860 |
|---|---|
| Receipt number | R000036384 |
| Scientific Title | TR study of "A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer (BIGBANG study)" |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/09/24 09:57:19 |
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Basic information
Public title
TR study of "A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer (BIGBANG study)"
Acronym
BIGBANG TR
Scientific Title
TR study of "A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer (BIGBANG study)"
Scientific Title:Acronym
BIGBANG TR
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore biomarker relating to efficacy or resistance of combination therapy consisting of BRAF inhibitor (encorafenib), MEK inhibitor (binimetinib), and an anti-epidermal growth factor receptor (EGFR) antibody (cetuximab) in patients with BRAF non-V600E mutated metastatic CRC
Basic objectives2
Others
Basic objectives -Others
Biomarker research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer related genome analysis, gene expression and molecular characterization analysis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients enrolled in BIGBANG study
2.Written informed consent
Key exclusion criteria
None
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
2778577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
0471331111
BIGBANG_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kotani |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
0471331111
Homepage URL
BIGBANG_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Cancer Center Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center IRBoffice
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
0471331111
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知県がんセンター中央病院 (愛知県)、国立がん研究センター東病院（千葉県）、九州がんセンター(福岡県)、四国がんセンター(愛媛県)、北海道大学病院(北海道)、聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
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
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cancer related genome analysis, gene expression analysis, molecular characterization analysis
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
