UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031221 |
|---|---|
| Receipt number | 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 | 2021/09/24 09:34:44 |
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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
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
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
BRAVERY_core@east.ncc.go.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
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
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
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
Completed
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
| 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=R000035488
