UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017114
Receipt number 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 13:55:44

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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 or person

Institute

National Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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