UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022964
Receipt number R000026475
Scientific Title A phase I study of the combination chemotherapy of IRISOX (irinotecan/S-1/oxaliplatin) in gemcitabine-refractory pancreatic cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2020/01/06 17:44:16

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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 or person

Institute

Kitasato University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026475


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name