UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer
Title of the study (Brief title)	Phase II study of nab-paclitaxel in patients with previously treated 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 explore 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, 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 is administered at a dose of 100mg/m2 intravenously on day1,8,15. A treatment cycle is repeated every 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 diagnosis on non-small cell lung cancer. Non-small cell lung cancer with stage IIIB, stage IV, recurrent disease. 2)The patients who previously treated with the chemotherapy of 1 or 2 regimen including the platinum combination chemotherapy. Recurrence within 6 months or less from the adjuvant chemotherapy finished is considered a previous treatment. Patients with active EGFR mutations or ALK translocations need previously treated with EGFR-TKIs, Crizotinib, respectively. (but not count as 1 regimen) 3)Without treatment history of nab - paclitaxel or paclitaxel 4)Interval from previous chemotherapy EGFR-TKI, Crizotinib : more than 14 days Other chemotherapy: more than 28 days 5)Interval from previous palliative radiotherapy and surgery (for metastatic site) : more than 14 days after the last treatment 6)Interval from previous chest radiotherapy: more than 42 days after the last irradiation to lung 7)The presence of measureable lesions by RECIST 8)Age of 20 years or older 9)Performance Status (ECOG) 0 - 2 10)Adequate organ function Granulocyte count 1,500/mm3 or over Platelet count 100,000/mm3 or over Hb 9.0g/dL or over AST/ALT 2.5 x the Upper Limits of Normal (ULN) or under Total bilirubin 1.5mg/dL or under Serum creatinine 1.0 x the Upper Limits of Normal (ULN) or under SpO2 90 % or over 11)Life expectancy more than 3 months 12)Written informed consent to participate
Key exclusion criteria	1)Small cell carcinoma (in the whole or a part of the tumor) 2)Interstitial pneumonia or pulmonary fibrosis detectable on X ray 3)Uncontrolled pleural effusion, ascites, or pericardial effusion 4)Symptomatic brain metastasis 5)Active synchronous malignant neoplasm 6)Uncontrolled diabetes or hypertension 7)History of severe heart disease 8)Anamnesis of hypersensitivity to paclitaxel or albumin 9)Anamnesis of hypersensitivity to drugs 10)Patients with severe infection 11)Pregnancy or lactating patients 12)Patients who were judged inappropriate to entry this study by physician
Target sample size	30

Research contact person
Name of lead principal investigator	Asuka Tsuya
Organization	Osaka City General Hospital
Division name	Department of clinical oncology
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka 534, Japan
TEL	06-6929-1221
Email	a-tsuya@med.osakacity-hp.or.jp

Public contact
Name of contact person	Asuka Tsuya
Organization	Osaka City General Hospital
Division name	Department of clinical oncology
Address	2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka 534, Japan
TEL	06-6929-1221
Homepage URL
Email	a-tsuya@med.osakacity-hp.or.jp

Sponsor
Institute	Osaka City General Hospital
Institute
Department

Funding Source
Organization	Osaka City General 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	2013 Year 10 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 28 Day
Anticipated trial start date	2013 Year 04 Month 12 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	2013 Year 10 Month 23 Day
Last modified on	2017 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014133