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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027648
Receipt No. R000031678
Scientific Title A poilot study of eribulin monotherapy in chemorefractory patients with BRAF V600E-mutant metastatic colorectal cancer
Date of disclosure of the study information 2017/06/05
Last modified on 2018/06/06

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Basic information
Public title A poilot study of eribulin monotherapy in chemorefractory patients with BRAF V600E-mutant metastatic colorectal cancer
Acronym BRAVE PILOT study
Scientific Title A poilot study of eribulin monotherapy in chemorefractory patients with BRAF V600E-mutant metastatic colorectal cancer
Scientific Title:Acronym BRAVE PILOT study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the efficacy and safety of eribulin monotherapy in a few patiets with BRAF V600E-mutant chemorefractory metastatic colorectal cancer and to determine whether a phase II study of eribulin monotherapy should be conducted.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective response rate; ORR
Key secondary outcomes Progression-free survival; PFS
Time to treatment failure; TTP
Overall survival; OS
Disease control rate; DCR
Safety

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 1.4 mg/m2 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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histologically proven adenocarcinoma of colorectal cancer
(2) BRAF V600E mutant
(3) Unresectable metastatic colorectal cancer
(4) Refractory or intolerable to fluoropyrimidine-based first-line chemotherapy
(5) ECOG Performance Status of 0 or 1
(6) >=20 and <=75 years old
(7) With measureable disease according to RECIST version1.1
(8) Adequate organ function
(9) Written informed consent
Key exclusion criteria (1) Symptomatic brain, pia mater, or meningeal metastasis
(2) Active infection
(3) Interstitial pneumonia or pulmonary fibrosis
(4) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus, cerebral infarction, cerebral hemorrhage)
(5) Massive pleural, abdominal, or pericardial effusion with continuous drainage
(6) Active gastrointestinal hemorrhage
(7) Clinically significant mental disorder
(8) Previous treatment with eribulin
(9) Women who are pregnant or patients who are unwilling to avoid pregnancy
(10) Patients who are inappropriate for the study in the opinion of the investigator
Target sample size 5

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroya Taniguchi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Email h.taniguchi@aichi-cc.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshiki Masuishi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Homepage URL
Email tmasuishi@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 05 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 Terminated
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 06 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 05 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031678

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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