UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016583 |
|---|---|
| Receipt number | R000019239 |
| Scientific Title | ZELBORAF Special Drug Use Surveillance (Malignant Melanoma) |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2023/05/30 17:05:16 |
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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 | Nomura |
| Middle name | |
| Last name | Makoto |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japa
TEL
03-3281-6611
nomuramkt@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ryousuke |
| Middle name | |
| Last name | Harada |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
haradarus@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
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
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
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019239
