UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018233 |
|---|---|
| Receipt number | R000021104 |
| Scientific Title | Phase 2 study of Nab-Paclitaxel for patients with previously treated EGFR wild-type non-small-cell lung cancer. |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2019/01/08 15:09:06 |
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Basic information
Public title
Phase 2 study of Nab-Paclitaxel for patients with previously treated EGFR wild-type non-small-cell lung cancer.
Acronym
Phase 2 study of Nab-Paclitaxel for patients with previously treated EGFR wild-type non-small-cell lung cancer.
Scientific Title
Phase 2 study of Nab-Paclitaxel for patients with previously treated EGFR wild-type non-small-cell lung cancer.
Scientific Title:Acronym
Phase 2 study of Nab-Paclitaxel for patients with previously treated EGFR wild-type 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
To examine the efficacy and safety of the Nab-Paclitaxel for patients with previously treated non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
responce rate
Key secondary outcomes
adverse event, QOL, Dose intensity
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
Nab-Paclitaxel
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)Histologically or cytologically confirmed non-small-cell lung cancer and unresectable or postoperative recurrence NSCLC
2)Measurable lesions
3)Preceding anticancer agent treatment was provided and was taken as PD
4)ECOG PS 0-2
5)Adequate function of main organ
6)Do not have peripheral neuropathy, or cases less than G1
7)Provided written informed consent
Key exclusion criteria
1)Brain metastasis with the symptom
2)Active interstitial pneumonia or pulmonary fibrosis
3)Body fluid retention to need waste fluid
4)Hypersensitivity for paclitaxel or albumin
5)Pregnant or nursing female or man without the intention of the contraception
6)Active concomitant malignancy
7)Inappropriate patients for this study judged by the physicians
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hamaguchi Megumi |
Organization
Shimane university hospital
Division name
Clinical oncology and Respiratory medicine
Zip code
Address
89-1, Enya-cho, Izumo city, Shimane prefecture, Japan
TEL
0853-20-2580
hs1219@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hamaguchi Megumi |
Organization
Shimane university hospital
Division name
Clinical oncology and Respiratory medicine
Zip code
Address
89-1, Enya-cho, Izumo city, Shimane prefecture, Japan
TEL
0853-20-2580
Homepage URL
hs1219@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2015 | Year | 07 | Month | 07 | 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
| 2013 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | 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
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021104
