UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029198 |
|---|---|
| Receipt number | R000033355 |
| Scientific Title | Biweekly TAS-102 with Bevacizumab combination study |
| Date of disclosure of the study information | 2017/09/28 |
| Last modified on | 2020/03/23 19:11:50 |
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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 | Takeshi |
| Middle name | |
| Last name | Kato |
Organization
National Hospital Organization Osaka National Hospital
Division name
Surgery
Zip code
540-0006
Address
2-1-14 Hoenzaka, Chuoku, Osaka-city
TEL
06-6942-1331
ken-kato@momo.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hironaga |
| Middle name | |
| Last name | Satake |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Medical Oncology
Zip code
650-0047
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo
TEL
81783024321
Homepage URL
hsatake@kcho.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network(ECRIN)
Institute
Department
Personal name
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
ECRIN
Address
21-7 Sannou-cho, Shogoin, Sakyo-ku, Kyoto City
Tel
075-762-1200
miya@ecrin.or.jp
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
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
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 06 | Day |
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
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033355
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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