UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019828 |
|---|---|
| Receipt number | 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 | 2024/08/19 11:00:04 |
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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 | Kentarao |
| Middle name | |
| Last name | Yamazaki |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
k.yamazaki@scchr.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
4648681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
052-762-6111
Homepage URL
h.taniguchi@aichi-cc.jp
Sponsor or person
Institute
Pharma Valley Center
Institute
Department
Personal name
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
Shizuoka Cancer Center Institutional Review Board
Address
1007 Shimonagakubo Nagaizumi SuntoGun Shizuoka
Tel
055-989-5222
rinsho_office@scchr.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
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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 09 | Day |
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
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022906
