UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027648 |
|---|---|
| Receipt number | 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 11:28:43 |
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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
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
h.taniguchi@aichi-cc.jp
Public contact
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
tmasuishi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031678
