UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of nab-paclitaxel for pretreated NSCLC
Title of the study (Brief title)	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	Satoshi Igawa
Organization	Kitasato university hospital
Division name	Respiratory medicine
Address	1-15-1, Kitasato, Minamiku, Sagamihara, Kanagawa
TEL	042-777-8111
Email	igawa@kitasato-u.ac.jp

Public contact
Name of contact person	Satoshi Igawa
Organization	Kitasato university hospital
Division name	Respiratory medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016708