UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of nab-paclitaxel for pretreated non-small cell lung cancer
Title of the study (Brief title)	A phase II study of nab-paclitaxel for pretreated 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 efficacy and safety of nab-paclitaxel in patients with previously treated non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival, Progression free survival, frequency of adverse events

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 is administered at a dose of 100mg/m2 intravenously on day1,8,15. A treatment cycle is repeated every 21-28 days.
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 2)unresectable disease 3)The presence of measureable lesions 4)Age of 20 years or older 5)Life expectancy more than 12weeks 6)ECOG Perfomance status 0-2 7) Previous 1-2 regimen chemotherapy consisting of platinum 8)oral UFT for adjuvant chemotherapy do not count as 1 regimen 9)EGFR-TKI or ALK inhibiter do not count as 1 regimen 10)Interval of more than 28 days from the last chemotherapy or radiotherapy 11)preserved organ's function WBC>=3,000/mm3 Hemoglobin>= 9.0g/dl Platelet count>=100,000/mm3 Total serum bilirubin <=1.5 mg/dl GOT/GPT <100 IU/l Serum creatinine <=1.5mg/dl 12)Acquisition of written informed consent
Key exclusion criteria	1)patients previously treated with paclitaxel derivative drugs 2)Anamnesis of hypersensitivity to albumin 3)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case) 4)evident pericardial effusion 5)serious complications below uncontrollable angina pectoris, myocardial infarction within 3 months or heart failure uncontrollable diabetes uncontrollable hypertension severe infection 6)pulmonary fibrosis or interstitial pneumonitis evident 7)HB and HC virus carrier 8)now pregnant or lactation 9)difficult to perform or continue of this study
Target sample size	30

Research contact person
Name of lead principal investigator	Kozo Yamada
Organization	Kanagawa Cancer Center
Division name	Department of Thoracic Oncology
Address	2-3-2,Nakao, Asahi-ku, Yokohama-city, Kanagawa, Japan
TEL	045-520-2222
Email	yamadak@kcch.jp

Public contact
Name of contact person	Shuji Murakami
Organization	Kanagawa Cancer Center
Division name	Department of Thoracic Oncology
Address	2-3-2,Nakao, Asahi-ku, Yokohama-city, Kanagawa, Japan
TEL	045-520-2222
Homepage URL
Email	murakamis@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

Funding Source
Organization	Kanagawa Cancer Center
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 01 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 11 Day
Anticipated trial start date	2013 Year 11 Month 19 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 01 Month 27 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014411