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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023277
Receipt No. R000026768
Scientific Title Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Date of disclosure of the study information 2016/07/21
Last modified on 2017/08/03

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Basic information
Public title Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Acronym Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Scientific Title Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Scientific Title:Acronym Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and to determine the recommended phase II dose of FOLFOXIRI plus ramucirumab
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Dose-limiting toxicity in the first cycle
Key secondary outcomes Objective response rate, progression-free survival (PFS), PFS2, time to treatment failure, overall survival, and safety

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 FOLFOXIRI plus ramucirumab
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. Histopathologically confirmed adenocarcinoma of colon or rectum (excluding vermiform appendix and proctos)
2. Not resectable metastatic colorectal cancer
3. Age 20-75 at study entry
4. ECOG PS of 0 or 1 at study entry (PS of 0 if age 71-75)
5. Measurable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
6. No prior chemotherapy for advanced disease (previous adjuvant therapy by fluoropyrimidine monotherapy is allowed if more than 24 weeks have elapsed between the end of adjuvant therapy and first relapse)
7. Adequate organ function
8. UGT1A1 genotype tested. Categorized into Wild (*1/*1) or single Hetero (*1/*28, *1/*6)
9. Written informed consent obtained prior to any study specific procedures
Key exclusion criteria 1. Serious complications (e.g. other active co-existing malignancies, brain metastases, and malignant coelomic fluid required drainage)
2. Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks.
3. Grade >=2 peripheral neuropathy
4. Administration of blood transfusion or G-CSF within 2 weeks
5. Thromboembolism (grade 3 or higher) within 6 months
6. Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size 9

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 411-8777, Japan
TEL 055-989-5222
Email k.yamazaki@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Kito
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Homepage URL
Email kitoyo9100@gmail.com

Sponsor
Institute Pharma Valley Center
Institute
Department

Funding Source
Organization Shizuoka Cancer Center
Organization
Division
Category of Funding Organization Local Government
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 愛知県がんセンター中央病院
九州がんセンター
神戸市立医療センター中央市民病院
静岡県立静岡がんセンター
聖マリアンナ医科大学病院
千葉県がんセンター
筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 21 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
2016 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 25 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
2016 Year 07 Month 21 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026768

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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