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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name