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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031221
Receipt No. R000035488
Scientific Title A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer
Date of disclosure of the study information 2018/03/26
Last modified on 2020/08/17

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Basic information
Public title A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer
Acronym BRAVERY study
Scientific Title A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer
Scientific Title:Acronym BRAVERY study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Confirmed objective response rate(ORR) by investigators' assessment
Key secondary outcomes Progression-free survival;PFS
Duration of response;DoR
Disease control rate;DC
Overall survival;OS
Incidences of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eribulin is administered intravenously at a dose of 1.4mg/m^2/day on Days 1 and 8, repeated every 21 days.
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.Written informed consent
2.Age of 20 years or older
3.Confirmed diagnosis of metastatic colorectal cancer (mCRC) by tissue diagnosis
4.Refractory or tolerate to at least one regimen (including irinotecan or oxaliplatin) containing fluoropyrimidine for mCRC
5.BRAF V600E mutant CRC
6.Measurable lesions according to RECIST version 1.1
7.Being able to provide FFPE colorectal cancer tissue
8.PS:0-1
9.Life expectancy of 3 months or longer
10.Adequate organ function
11.Women of childbearing potential who are negative in a urine pregnancy test and agree to take appropriate precautions to avoid pregnancy from screening through 90 days after the final administration of eribulin
Key exclusion criteria 1.History of treatment with eribulin
2.Symptomatic brain metastases or meningeal dissemination
3.Leptomeningeal disease
4.Medical history of clinically significant cardiac diseases
5.History of other malignant tumors within 3 years before the start of study treatment.
6.Previous treatment with any of the following:
a.Last dose of cytotoxic agents or regorafenib within 14 days
b.Last dose of cetuximab, panitumumab, bevacizumab, aflibercept, or ramucirumab within 3 weeks
c.Last dose of biologic therapy (except cetuximab, panitumumab, bevacizumab, aflibercept, or ramucirumab), immunotherapy, non-marketed investigational anticancer treatments within 4 weeks
d.Prior radiotherapy to 30% of bone marrow
e.Major surgery within 2 weeks
7.Known HIV infection
8.Positive HBs antigen
9.Diagnosed as liver cirrhosis
10.Female patients who are breastfeeding
11.Other medically important abnormalities
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Hiroya
Middle name
Last name Taniguchi
Organization National Cancer Center Hospital East
Division name Department of GI Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email BRAVERY_core@east.ncc.go.jp

Public contact
Name of contact person
1st name Toshiki
Middle name
Last name Masuishi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code 4648681
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
TEL 052-764-6111
Homepage URL
Email BRAVERY_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Project of Translational and Clinical Research Core Centers

IRB Contact (For public release)
Organization National Cancer Center Hospital Institutional Review Board
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
Tel 04-7133-1111
Email irboffice@east.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(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)、がん研究会有明病院(東京都)、大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 26 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 30
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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 24 Day
Date of IRB
2018 Year 02 Month 28 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2020 Year 09 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2020 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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