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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019828
Receipt No. R000022906
Scientific Title A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin
Date of disclosure of the study information 2015/12/15
Last modified on 2016/11/28

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Basic information
Public title A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients
with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin
Acronym A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients
with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin (MODURATE study)

MODURATE study
Scientific Title A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients
with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin
Scientific Title:Acronym A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients
with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplatin (MODURATE study)

MODURATE study
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and determine the recommended phase II dose of TAS-102, irinotecan and bevacizumab.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Part1(dose-escalation): DLT between first 2 cycles
Part2(expansion): the incidence of febrile neutropenia
Key secondary outcomes Progression free survival
Time to treatment failure
Overall survival
Objective response rate
Disease control rate
Safety

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 TAS-102 25-35 (mg/m2) day1-5
CPT-11 150-180 (mg/m2) day 1
Bevacizumab 5 (mg/kg) day 1
every 2 weeks
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven adenocarcinoma of unresectable colorectal cancer
2) Resistant or intolerant to fluoropyrimidine and oxaliplatin
3) No prior irinotecan, TAS-102 or regorafenib-containing chemotherapy
4) With measurable lesions according to RECIST version1.1
5) ECOG performance status of 0 or 1
6) 20<= and 75>= years old
7) Adequate organ function
8) No pregnancy
9) Written informed consent
Key exclusion criteria 1) Serious illness such as brain metastasis, systemic infection or gastrointestinal bleeding.
2) Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks.
3) Adverse events due to prior chemotherapy
4) Administration of blood transfusion or G-CSF within 2 weeks
5) Severe pulmonaly disorder
6) Thromboembolism (grade3 or higher) within 6 months
7) Inappropriate for the study in the opinion of the investigator
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Yamazaki
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL 055-989-5222
Email k.yamazaki@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroya Taniguchi
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Homepage URL
Email h.taniguchi@aichi-cc.jp

Sponsor
Institute Pharma Valley Center
Institute
Department

Funding Source
Organization Taiho Pharma
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 静岡県立静岡がんセンター(静岡県)、愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 15 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 09 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
2015 Year 11 Month 17 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022906

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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