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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029198
Receipt No. R000033355
Scientific Title Biweekly TAS-102 with Bevacizumab combination study
Date of disclosure of the study information 2017/09/28
Last modified on 2018/07/14

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Basic information
Public title Biweekly TAS-102 with Bevacizumab combination study
Acronym BiTS study
Scientific Title Biweekly TAS-102 with Bevacizumab combination study
Scientific Title:Acronym BiTS study
Region
Japan

Condition
Condition metastatic colorectal carcinoma
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of biweekly TAS-102 plus bevacizumab for salvage line mCRC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase Ib part
MTD
Phase II part
16w PFS rate by investigators' assessmenT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 biweekly TAS-102 plus Bevacizumab
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. age >= 20y
3. histologically proven colorectal adenocarcinoma with metastatic disease
4. prior treatment history including fluoropyrimidine, irinotecan, oxaliplatin and anti-EGFR (in case of RAS WT)
5. ECOG PS <2
6. capable oral intake
7. evaluable lesions on the basis of RECIST v1.1
8. adequate organ function
a. Hb >= 8.0 g/dL
b. Neutrophil >= 1500/ mm3
c. Plt >= 75,000/ mm3
d. T-Bil <= 1.5 md/dL
e. AST/ALT <=100IU/L (in case of liver metastasis <= 200 IU/L)
f. serum creatinine <= 1.5 md/dL
9. a woman who have no plan to get pregnant
10. with an appropriate mental capacity
Key exclusion criteria 1. any of the following complication:
a. synchronous active malignancies other than carcinoma in situ or mucosal cancer
b. central nervous system metastases
c. active infection
d. uncontrolled ascites, pleural effusion, pericardial effusion
e. bowel obstruction, renal failure, liver failure,
effusion
f. uncontrolled DM
g. uncontrolled hypertension
h. symptomatic heart disease within 12 months
i. active gastrointestinal bleeding
j. uncontrolled HIV infection, HBV infection, HCV infection
k. immunodeficency
l. sever mental disorder
2. any of the following treatment:
a. thoracotomy, or intestinal resection within 4 weeks
b. chemotherapy within 1 week
c. extensive radiotherapy
d. investigational new drug within 1 week
3. history of TAS-102
4. grade 2 or more adverse events not recovered
5. transfusion within 7 days
6. urine dipstick for proteinuria more than +2
7. severe thrombosis or severe pulmonary disease
8. unhealed wound
9. hemorrhagic diathesis
10. pregnant and lactating females
11. patients judged by the investigator as unfit to be enrolled in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kato
Organization National Hospital Organization Osaka National Hospital
Division name Surgery
Zip code
Address 2-1-14 Hoenzaka, Chuoku, Osaka-city
TEL 06-6942-1331
Email ken-kato@momo.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironaga Satake
Organization Kobe City Medical Center General Hospital
Division name Department of Medical Oncology
Zip code
Address 2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
TEL 81783024321
Homepage URL
Email hsatake@kcho.jp

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network(ECRIN)
Institute
Department

Funding Source
Organization Taiho Pharmaceutical
Organization
Division
Category of Funding Organization Profit organization
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 09 Month 28 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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2018 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033355

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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