UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 study of Nab-Paclitaxel for patients with previously treated EGFR wild-type non-small-cell lung cancer.
Title of the study (Brief title)	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	Hamaguchi Megumi
Organization	Shimane university hospital
Division name	Clinical oncology and Respiratory medicine
Address	89-1, Enya-cho, Izumo city, Shimane prefecture, Japan
TEL	0853-20-2580
Email	hs1219@med.shimane-u.ac.jp

Public contact
Name of contact person	Hamaguchi Megumi
Organization	Shimane university hospital
Division name	Clinical oncology and Respiratory medicine
Address	89-1, Enya-cho, Izumo city, Shimane prefecture, Japan
TEL	0853-20-2580
Homepage URL
Email	hs1219@med.shimane-u.ac.jp

Sponsor
Institute	Shimane university hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021104