UMIN-CTR Clinical Trial

Basic information
Public title	A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Acronym	IRISOX for gemcitabine-refractory pancreatic cancer
Scientific Title	A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Scientific Title:Acronym	IRISOX for gemcitabine-refractory pancreatic cancer
Region	Japan

Condition
Condition	gemcitabine-refractory pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to determine the recommended dose for the phase I study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Phase I: MTD, RD
Key secondary outcomes	Safety, Response rate, Progression free survival, Overall survival

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	CPT-11: dose escalation S-1: fixed dose L-OHP: fixed dose
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.Pathologically proven Adenocarcinoma or Adenosquamous carcinoma 2.resistant /intolerable to gemcitabine 3.with a rest longer than 14 days after the end of prior therapy 4.Age 20-75 5.ECOG PS of 0-1 6.expected survival period longer than 2 months 7.Sufficient oral intake 8.The subject has measurable disease. 9.Adequate organ functions 10.Written informed consent
Key exclusion criteria	1.Patients with contraindication for the medication of Irinotecan, S-1 and L-OHP 2.History of serious drug hypersensitivity or a history of drug allergy 3.Pregnancy 4.Active infection 5.Severe complications (Grade 3,4 CTCAE v4.0) 6.Peripheral neuropathy(Grade 2,3,4 CTCAE v4.0) 7.Serious diarrhea(Grade 2,3,4 CTCAE v4.0) 8.Intestinal pneumonitis or pulmonary fibrosis 9.Much ascites or pleural effusion or pericardial effusion 10.Active double cancer 11.Symptomatic brain metastasis 12.Regular use of frucitocin, fenitoin or warfarin 13.Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene 14.Active Hepatitis B 15.Inappropriate for this study judged by the attending physician
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Kida
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Email	m-kida@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Okuwaki
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL	+81-42-778-8111
Homepage URL
Email	kokuwaki@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Kitasato University
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel	+81-42-778-8111
Email	rinri@med.kitasato-u.ac.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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 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	12
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 06 Month 28 Day
Date of IRB	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
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 01 Day
Last modified on	2020 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026475