UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phaseII study of nab-paclitaxef in patients with pretreated advanced non-small-cell lung cancer.
Title of the study (Brief title)	A phaseII study of nab-paclitaxef in patients with pretreated advanced 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 evaluate the feasibility and efficacy of nab-paclitaxel in patients with pretreated advanced non-small-cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate progression free survival
Key secondary outcomes	Progression free survival, Overall Survival, Safety

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 100mg/m2 Day1,8,15 Every four weeks
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 proven stage IIIB/IV non-small cell lung cancer 2) Pretreated with one regimen. 3) ECOG PS : 0-2 4) chemo na&#239;ve 5) Adequate organ function 6) Age: 20- years old 7) At least one measurable lesion by RECIST 8)without other active double cancer. 9) Life expectancy more than three months 10) Written informed consent
Key exclusion criteria	1)With severe myelosupression. 2) With active infectious disease 3) Interstitial pneumonia or pulmonary fibrosis detectable on X ray 4)History of cardiac dysfunction 5)History of treatment with paclitaxel. 6)History of albumin sensitivity 7)Symptomatic brain metastasis 8)Pericardial or pleural effusion requiring drainage 9) History of serious disease condition 10) History of drug allergy 11) With pregnancy or lactation 12) Without measurable lesion by RECIST 13) With grade2 or more neuropathy 14) Evaluated to be ineligible by a physician for other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Takayasu Kurata
Organization	Kansai Medical University Hirakata Hospital
Division name	Thoracic oncology
Address	2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL	072-804-0101
Email	kuratat@hirakata.kmu.ac.jp

Public contact
Name of contact person	Takashi Yokoi
Organization	Kansai Medical University Hirakata Hospital
Division name	Thoracic oncology
Address	2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL	072-804-0101
Homepage URL
Email	yokoit@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	Kansai Medical University Hirakata Hospital
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	2014 Year 06 Month 09 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 07 Day
Anticipated trial start date	2014 Year 06 Month 09 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 07 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016536