UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021311 |
|---|---|
| Receipt number | R000022107 |
| Scientific Title | phase 2 study of the combination therapy, docetaxel and trastuzumab, for advanced extramammary Paget's disease. |
| Date of disclosure of the study information | 2016/03/03 |
| Last modified on | 2023/11/16 14:56:30 |
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Basic information
Public title
phase 2 study of the combination therapy, docetaxel and trastuzumab, for advanced extramammary Paget's disease.
Acronym
phase 2 study of the combination therapy, docetaxel and trastuzumab, for advanced extramammary Paget's disease.
Scientific Title
phase 2 study of the combination therapy, docetaxel and trastuzumab, for advanced extramammary Paget's disease.
Scientific Title:Acronym
phase 2 study of the combination therapy, docetaxel and trastuzumab, for advanced extramammary Paget's disease.
Region
| Japan |
Condition
Condition
extramammary Paget's disease
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate the safety and efficacy of the combination chemotherapy (docetaxel and trastuzumab) for HER2-positive advanced stage extramammary Paget's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, Efficacy(ORR)
Key secondary outcomes
duration of overall response
duration of stable disease
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
Chemotherapy Q3W, 3 cycle
docetaxel 75mg/sqm
trastuzumab 8mg/kg(first cycle), 6mg/kg(second, third cycle)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Have histologically confirmed extramammary Paget's disease as follows.
unresectable or metastatic disease
Her-2 positive
2) Provide written informed consent for the study.
3) Be male or female subjects, age 20 years or older on day of signing consent.
4) LVEF >= 50%
5) Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
6) Have the presence of at least one measurable lesion by CT or MRI per RECIST 1.1 criteria.
7) Have laboratory parameters within Protocol-defined range.
a) Absolute neutrophil count >= 1,500 /mm3
b) Platelets >= 100,000 /mm3
c) Hemoglobin >= 10 g/dL
d) Bilirubin <= 2.0 mg/dL
e) AST and ALT <= 100 IU/L
g) Serum creatinine <= 1.5mg/dL
8) Prior therapy for extramammary Paget's disease was completed at least 4 weeks before treatment initiation.
Key exclusion criteria
1) Have a history of hypersensitivity to components of the chemotherapeutic drugs
2) Women who may possibly be pregnant or pregnant
3) Patients with severe cardiac dysfunction
4) Has known active central nervous system (CNS) metastasis.
5) Has uncontrolled disease that might confound the results of the study, or is not best interest of the subject to participate, in the opinion of the treating investigator.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Takeru |
| Middle name | |
| Last name | Funakoshi |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3823
takeruf@a8.keio.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Hirai |
Organization
Keio University School of Medicine
Division name
Depertment of Dermatology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3823
Homepage URL
ih831221@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Chugai Pharmaceutical Co., LTD.
ELMED EISAI Co., Ltd.
IRB Contact (For public release)
Organization
Certified Review Board of Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-nintei-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180073
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 03 | 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
13
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
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | 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 | 03 | Month | 03 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022107
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| Registered date | File name |
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