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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018293
Receipt No. 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

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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
Email 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
Email akk-koo@nms.ac.jp

Sponsor
Institute NIPPON MEDICAL SCHOOL MUSASHI KOSUGI HOSPITAL
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020787

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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