UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018293 |
|---|---|
| Receipt number | R000020787 |
| Scientific Title | Feasibility study of a short Bevacizumab infusion in patients. |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2019/04/24 13:26:15 |
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Basic information
Public title
Feasibility study of a short Bevacizumab infusion in patients.
Acronym
Feasibility study of a short Bevacizumab infusion in patients.
Scientific Title
Feasibility study of a short Bevacizumab infusion in patients.
Scientific Title:Acronym
Feasibility study of a short Bevacizumab infusion in patients.
Region
| Japan |
Condition
Condition
colorectal cancer,breast cancer,ovarian cancer, lung cancer, cervical cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety profile of a short infusion of Bevacizumab in Japanese patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Having onset of hypersensitivity reaction or not
Key secondary outcomes
grade of infusion related
reaction(CTCAE v.4.0),feasibility
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 | Maneuver |
Interventions/Control_1
Bevacizumab is administered in 0.5mg/kg/min.
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)meet the administration criteria of bevacizumab
2)outpatients
3)Age 20 years and above
4)ECOG PS 0-2
5)No prior therapy of bevacizumab
6)Written informed consent
Key exclusion criteria
1)Systemic administration of corticosteroids
2)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Konomatsu |
Organization
NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Division name
Pharmacy
Zip code
Address
1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA
TEL
044-733-5181
akk-koo@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Konomatsu |
Organization
NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Division name
Pharmacy
Zip code
Address
1-396,KOSUGI-CHO NAKAHARAKU,KAWASAKI KANAGAWA
TEL
044-733-5181
Homepage URL
akk-koo@nms.ac.jp
Sponsor or person
Institute
NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本医科大学武蔵小杉病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020787
