UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A poilot study of eribulin monotherapy in chemorefractory patients with BRAF V600E-mutant metastatic colorectal cancer
Title of the study (Brief title)	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	Hiroya Taniguchi
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL	052-762-6111
Email	h.taniguchi@aichi-cc.jp

Public contact
Name of contact person	Toshiki Masuishi
Organization	Aichi Cancer Center Hospital
Division name	Department of Clinical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031678