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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016583
Receipt No. R000019239
Scientific Title ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)
Date of disclosure of the study information 2015/02/26
Last modified on 2019/03/29

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Basic information
Public title ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)
Acronym ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)
Scientific Title ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)
Scientific Title:Acronym ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)
Region
Japan

Condition
Condition Malignant Melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to determine the following items under the conditions of actual clinical use of Zelboraf in a long-term follow-up period (24 months) according to the post-approval commitments.
1. Incidence of adverse drug reactions (ADRs)
2. Unlabeled ADRs
3. Overall Survival (OS)
4. Factors thought to affect safety and effectiveness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse reaction incidence
Key secondary outcomes Effectiveness
OS

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 All patients planning to use Zelboraf during the enrollment period
Key exclusion criteria No criteria
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kawashima
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real world data science Dept
Zip code 103-8324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japa
TEL 03-3273-0769
Email mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Ayaka
Middle name
Last name Shimizu
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real world data science Dept
Zip code 103-8324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Homepage URL
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical 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 None
Address None
Tel None
Email None

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
2015 Year 02 Month 26 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
2015 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patent baseline characteristics,Treatment history of primary disease,Treatment history of non-primary disease,Treatment status,Concomitant drugs,Combination therapy,Outcome,Patient transfer information,Post-transfer information,Adverse events (AEs),Follow-up items for cases of serious adverse events

Management information
Registered date
2015 Year 02 Month 19 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019239

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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