UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Title of the study (Brief title)	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	Kentaro Yamazaki
Organization	Shizuoka Cancer Center
Division name	Division of Gastrointestinal Oncology
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	Yosuke Kito
Organization	Shizuoka Cancer Center
Division name	Division of Gastrointestinal Oncology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026768