UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017702 |
|---|---|
| Receipt number | R000016838 |
| Scientific Title | KADCYLA drug use surveillance |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2019/04/05 18:26:54 |
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Basic information
Public title
KADCYLA drug use surveillance
Acronym
KADCYLA drug use surveillance
Scientific Title
KADCYLA drug use surveillance
Scientific Title:Acronym
KADCYLA drug use surveillance
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Endocrine surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety
- Understand the onset profile of adverse drug reactions (selected adverse event: platelet count decreased, impaired liver function)
- Find unexpected adverse drug reactions
- Understand factors that may affect the safety of KADCYLA
To assess the effectiveness
- Understand response rate based on evaluation by attending physicians
- Understand factors that may affect the effectiveness of KADCYLA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety;ADR occurence
Key secondary outcomes
Efficacy;Response rate per investigator assessment
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 with breast cancer who are scheduled to start receiving KADCYLA during this surveillance enrollment period at the first time.
Key exclusion criteria
No criteria
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kawshima |
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
03-3273-0769
kawashmaizm@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
shimizuayk@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
Not applicable for Drug use surveillance
Address
Not applicable for Drug use surveillance
Tel
Not applicable for Drug use surveillance
Not applicable for Drug use surveillance
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 | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Not opened
Publication of results
Unpublished
Result
URL related to results and publications
Not opened
Number of participants that the trial has enrolled
250
Results
The adverse drug reaction incidence rate in 250 examples of safety analysis was 69.60% (174/ 250 example), and the case number was 438, and platelet decreased number 54.40% (136/250 examples), aspartic acid AMINOTORANSUFERAZE increased 31.20 % (78/250 examples), ARANINAMINOTORANSUFERAZE increased 20.00 % (50/250 examples), liver function abnormal 8.00 % (20/250 examples) and nose bleeding 6.80 % (17/250 examples) met main adverse drug reactions (5% or more than of adverse drug reaction incidence rate).
Results date posted
| 2019 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient were all women and a pregnant woman wasn't included. By age basis, more than 15 years old, less than 65 years old, 60.00% (150/250 examples) and more than 65 years old, 40.00 % (100/250 examples) came.
Participant flow
258 patients of CRF were collected. Of these 250 pts were analysed for a safety analysis set.
Adverse events
The adverse drug reaction incidence rate in 250 examples of safety analysis was 69.60% (174/ 250 example), and the case number was 438, and platelet decreased number 54.40% (136/250 examples), aspartic acid AMINOTORANSUFERAZE increased 31.20 % (78/250 examples), ARANINAMINOTORANSUFERAZE increased 20.00 % (50/250 examples), liver function abnormal 8.00 % (20/250 examples) and nose bleeding 6.80 % (17/250 examples) met main adverse drug reactions (5% or more than of adverse drug reaction incidence rate).
Outcome measures
This surveillance will collect information on the following aspects of the use of KADCYLA under post-marketing conditions.
(1) Adverse drug reactions (events of interest: febrile neutropenia, interstitial lung disease)
(2) Unknown adverse drug reactions
(3) Response rate, as assessed by the attending physician
(4) Factors thought to affect safety or efficacy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient baseline characteristics, Treatment history of primary disease, Concomitant drugs, Combination therapy, Outcome, Adverse events
Management information
Registered date
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016838
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