UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020976 |
|---|---|
| Receipt number | R000024206 |
| Scientific Title | A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2019/02/12 18:26:59 |
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Basic information
Public title
A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer
Acronym
A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer
Scientific Title
A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer
Scientific Title:Acronym
A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
safety
Key secondary outcomes
objective response rate
progression free survival
disease control rate
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
Nivolumab
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age of 75 years old and older than 75 years old
2)Histologically and/or cytologically proven non-small cell lung cancer
3)Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease.
4)ECOG performance status 0-2.
5)previously treated with systemic chemotherapy
6)Adequate organ function
Key exclusion criteria
1)Subjects with interstitial lung disease which is detected by chest X-ray
3)Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry.
4)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes,
Intestinal obstruction.
5)known or suspected autoimmune disease, or receiving continuous systemic corticosteroid or immunosuppressant treatment.
6)Subjects with symptomatic CNS metastases or symptomatic carcinomatous meningitis. Subjects with asymptomatic CNS metastases, and subjects after 4 weeks from whole brain radiation therapy or 2 weeks from stereotactic brain radiation therapy can be included.
7)Radiation therapy within 4 weeks of the first dose of Nivolumab.
8)Subjects with known infection with HIV or AIDS
. Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection.
9)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
10)Dementia or psychological disorder difficult to participate in this clinical study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujitaka Kazunori |
Organization
Hiroshima University Hospital
Division name
respiratory medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima,
TEL
082-257-5555
fujikazu@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamaguchi Kakuhiro |
Organization
Hiroshima University Hospital
Division name
respiratory medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima,
TEL
082-257-5555
Homepage URL
yamaguchikakuhiro@gmail.com
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
