UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010841 |
|---|---|
| Receipt number | R000012691 |
| Scientific Title | Phase 2 trial of Abraxane, albumin-bound paclitaxel, in patients with previously treated non-small cell lung cancer |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2017/08/15 13:08:42 |
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Basic information
Public title
Phase 2 trial of Abraxane, albumin-bound paclitaxel, in patients with previously treated non-small cell lung cancer
Acronym
Phase 2 trial of albumin-bound paclitaxel in patients with previously treated non-small cell lung cancer
Scientific Title
Phase 2 trial of Abraxane, albumin-bound paclitaxel, in patients with previously treated non-small cell lung cancer
Scientific Title:Acronym
Phase 2 trial of albumin-bound paclitaxel in patients with previously treated non-small cell lung cancer
Region
| Japan |
Condition
Condition
Previously treated non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of Abraxane montherapy in patients with non-small cell lung cancer ptrviously treated by anticancer drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate and the rate without progressive disease
Key secondary outcomes
OS, PFS, and safety
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
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
Patients with non-small cell lung cancer previously trearted with one regimen of chemotherapy
Key exclusion criteria
Patients with non-small cell lung cancer previously trearted with paclitaxel
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
University of Fukui Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
tamotsui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
University of Fukui Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-8355
Homepage URL
tamotsui@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, Faculty of Medical Science, University of Fukui
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | 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
| 2013 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012691
