UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023277 |
|---|---|
| Receipt number | 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 00:43:25 |
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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
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
kitoyo9100@gmail.com
Sponsor or person
Institute
Pharma Valley Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026768
