UMIN-CTR Clinical Trial

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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