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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017114
Receipt No. R000019854
Scientific Title Multicenter Phase 1b/2 Trial of Nintedanib with TAS-102 in Patients with Metastatic Colorectal Cancer (mCRC) who had the progression or intolerant to standard therapies.
Date of disclosure of the study information 2015/04/13
Last modified on 2017/10/13

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Basic information
Public title Multicenter Phase 1b/2 Trial of
Nintedanib with TAS-102
in Patients with Metastatic Colorectal Cancer (mCRC) who had the progression or intolerant to standard therapies.
Acronym N-TASK FORCE
Scientific Title Multicenter Phase 1b/2 Trial of
Nintedanib with TAS-102
in Patients with Metastatic Colorectal Cancer (mCRC) who had the progression or intolerant to standard therapies.
Scientific Title:Acronym N-TASK FORCE
Region
Japan

Condition
Condition advanced colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 [Phase1b]
To determine a recommend dose of Nintedanib with TAS-102 in patients who had the progression or intolerant to standard therapies.
[Phase2]
To evaluate the efficacy and safety of combination Nintedanib with TAS-102 in patients who had the progression or intolerant to standard therapies.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes 16 weeks progression free survival rate ( 16W PFS rate)
Key secondary outcomes Overall survival:OS
PFS
Objective response rate:ORR
Disease control rate:DCR
Adverse event:AE
PK,PD

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 1 cycle is 28days.
Nintedanib (150mg or 200mg) is orally administered twice daily and TAS-102 (35mg/m2) is orally administered twice daily in 1-5days and 8-12 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)>=20 years old
3)Histologically or cytologically proven adenocarcinoma of colon or rectum (except appendiceal cancer), and KRAS test were carried out.
4)Prior chemotherapy was discontinued due to disease progression, or an adverse event.
5)No prior treatment with Regorafenib
6)ECOG Performance Status of 0 or 1

7)Adequate oral intake
8)With measurable disease according to RECIST
9)Adequate organ function within 14 days prior to enrollment.
a.Hemoglobin >=9.0 g/d
b.Absolute neutrophil count >=1,500 /mm3
c.Platelet count >=100,000 /mm3
d with no liver metastasis, AST/ALT<=ULNx1.5 and T-Bil<=UNL
with liver metastasis, AST/ALT<=ULNx2.5 and T-Bil<=UNL
e Serum creatinine <=1.5mg/dL
10)Women of childbearing potential must have a negative pregnancy test within 7days prior to enrollment. Patients who do have intention that uses effective contraception method until 6 months after administering investigational drug.
11)Patient is willing or able to comply with the protocol.
Key exclusion criteria 1)Serious coexisting illness as follows.
a. Active double cancer(s)
b. CNS metastasis
c. Uncontrollable infectious disease
d. Uncontrollable pleural effusion, ascites, or cardiac effusion
e. Ileus, interstitial pneumonia,renal failure, hepatic failure or cerebrovascular disorder
f. Uncontrolled diabetic
g. Uncontrolled hypertension
h. Cardiac infarction, serious angina or New York Heart Association Class III or IV within 6 months prior to the registration
i Gastrointestinal bleeding
j Positive HBs antigen, HCV antibody or HIV antibody
k. Need immunosuppressive therapy
l. Uncontrolled mental disease or the psychotic manifestation
2)Receive the treatment as follows.
a.Major surgery therapy within 4 weeks prior to enrollment.
b.Chemotherapy within 3 weeks prior to enrollment.
c. Wide field radiotherapy 4 weeks prior to enrollment or local radiotherapy 2 weeks prior to enrollment.
d.Other investigational drugs within 4 weeks prior to enrollment.
3)Prior treatment with TAS-102 or Nintedanib
4)Unrecovered AEs related to prior treatment are Grade >= 2 according to CTCAE.
5)Blood transfusion or G-CSF within 14 days prior to enrollment.
6)Serious renal failure or proteinuria >= 2+ within 7days prior to enrollment.
7)Thromboembolic event or serious Pulmonary complaints within one year
8)Uncomplete cure wound or traumatic fracture
9)Tendency to hemorrhages or taking antithrombotic medication
10) Women during pregnancy or lactation ,
11) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutoshi Kuboki
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email ykuboki@east.ncc.go.jp

Sponsor
Institute National Cancer Center

Institute
Department

Funding Source
Organization Boehringer Ingelheim Pharma GmbH & Co. GK
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 公益財団法人がん研究会有明病院(東京都)
静岡県立静岡がんセンター(静岡県)
国立病院機構四国がんセンター(愛媛県)
国立開発研究法人国立がん研究センター東病院(千葉県)
北海道大学病院(北海道)
埼玉県立がんセンター(埼玉県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2015 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 24 Day
Last follow-up date
2017 Year 09 Month 06 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 13 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019854

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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