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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041015
Receipt No. R000046793
Scientific Title Onivyde I.V. infusion 43 mg General Drug Use-Results Survey (Unresectable pancreatic cancer after disease progression following cancer chemotherapy)
Date of disclosure of the study information 2020/07/07
Last modified on 2020/07/06

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Basic information
Public title Onivyde I.V. infusion 43 mg General Drug Use-Results Survey (Unresectable pancreatic cancer after disease progression following cancer chemotherapy)
Acronym Onivyde General Drug Use-Results Survey (Pancreatic cancer)
Scientific Title Onivyde I.V. infusion 43 mg General Drug Use-Results Survey (Unresectable pancreatic cancer after disease progression following cancer chemotherapy)
Scientific Title:Acronym Onivyde General Drug Use-Results Survey (Pancreatic cancer)
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate Safety and Effectiveness of Onivyde I.V. Infusion 43 mg in patients with Unresectable Pancreatic Cancer after disease progression following cancer chemotherapy in clinical practice and to detect issues expeditiously.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall incidence of each ADRs and AEs (Safety Specifications of the Survey related)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are administered Onivyde for the first time to Unresectable pancreatic cancer after disease progression following cancer chemotherapy per standard clinical practice and per prescribing information. In addition, patients who are given consent to participation in the survey.
Key exclusion criteria No given consent to participation in the survey.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name KAMEYAMA
Organization NIHON SERVIER CO., LTD.
Division name MEDICAL AFFAIRS
Zip code 113-0033
Address Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 07024933214
Email satoshi.kameyama@servier.com

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name KAMEYAMA
Organization NIHON SERVIER CO., LTD.
Division name MEDICAL AFFAIRS
Zip code 113-0033
Address Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 07024933214
Homepage URL
Email satoshi.kameyama@servier.com

Sponsor
Institute NIHON SERVIER CO., LTD.
Institute
Department

Funding Source
Organization NIHON SERVIER CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization NIHON SERVIER CO., LTD.
Address Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
Tel 07024933214
Email satoshi.kameyama@servier.com

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
2020 Year 07 Month 07 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 Open public recruiting
Date of protocol fixation
2020 Year 04 Month 30 Day
Date of IRB
2020 Year 04 Month 30 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The survey will be conducted to be followed GPSP Ministerial Ordinance, relevant regulations and Operating Procedures to ensure the quality of the survey.

Management information
Registered date
2020 Year 07 Month 06 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046793

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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