UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014357 |
|---|---|
| Receipt number | R000016708 |
| Scientific Title | Phase II study of nab-paclitaxel for pretreated NSCLC |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2017/12/25 15:00:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of nab-paclitaxel for pretreated NSCLC
Acronym
nab-paclitaxel for pretreated NSCLC
Scientific Title
Phase II study of nab-paclitaxel for pretreated NSCLC
Scientific Title:Acronym
nab-paclitaxel for pretreated NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation the efficacy of nab-paclitaxel for patient with NSCLC
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
PFS,OS, safty
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 monotherapy
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
Diagnosed for NSCLC histologically.
Stage IIIb or IV
Age, over 20 years old.
ECOG PS: 0-2
Main organ functions are maintained.
Key exclusion criteria
Hypersensitivity for drugs and albumin.
patient with grade 2 of peripheral neuropathy.
Patient with severe infection.
Patient with
Patient with SVC.
Patient with uncontroled diabetes mellitus, angina,heart disease and gastrointestinal ulceration.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Igawa |
Organization
Kitasato university hospital
Division name
Respiratory medicine
Zip code
Address
1-15-1, Kitasato, Minamiku, Sagamihara, Kanagawa
TEL
042-777-8111
igawa@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Igawa |
Organization
Kitasato university hospital
Division name
Respiratory medicine
Zip code
Address
1-15-1, Kitasato, Minamiku, Sagamihara, Kanagawa
TEL
042-777-8111
Homepage URL
igawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university hospital, division of respiratory medicine
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016708
