UMIN-CTR Clinical Trial

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
Email	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
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	ECRIN
Address	21-7 Sannou-cho, Shogoin, Sakyo-ku, Kyoto City
Tel	075-762-1200
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033355