UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014357
Receipt No. 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

* 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
Email 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
Email igawa@kitasato-u.ac.jp

Sponsor
Institute Kitasato university hospital, division of respiratory medicine
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016708

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.