UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Study of nab-paclitaxel in Treated Patients with Advanced Non-Small Cell Lung Cancer
Acronym	Phase II Study of nab-paclitaxel in Pretreated Patients with NSCLC
Scientific Title	Phase II Study of nab-paclitaxel in Treated Patients with Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym	Phase II Study of nab-paclitaxel in Pretreated Patients with NSCLC
Region	Japan

Condition
Condition	Treated patients with advanced non-small cell lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of nab-paclitaxel in treated patients with advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	RR: response rate
Key secondary outcomes	PFS: progression free survival OS: overall survival DCR: disease control rate Toxicity

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 q3weeks
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-sqamous non-small-cell lung cancer with chemotherapy treated patients 2) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease 4) ECOG performance status 0-2 5) Adequate organ function 6) Excepted to live over 3 months after administration day 7) Written informed consent from the patients
Key exclusion criteria	1) Interstitial pneumonia/lung fibrosis on chest CT. 2) Previous drug allergy 3) History of poorly controlled pleural effusion, pericardial effusion and ascites. 4) Active infection. 5) Current Diarrhea. 6) Ileus or intestinal tract paralysis. 7) Symptomatic brain metastasis. 8) Active concomitant malignancy. 9) History of sever heart disease. 10) History of sever psychological disease. 11) Those judged to be not suitable by the attending physician.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoya Middle name Last name Kawaguchi
Organization	Graduate School of Medicine, Osaka City University
Division name	Department of Respiratory Medicine
Zip code	545-8586
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	0666453793
Email	i-gakumu@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Naruo Middle name Last name Naruo
Organization	Tohoku Medical and Pharmaceutical University
Division name	Department of pulmonology
Zip code	545-8586
Address	1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN
TEL	022-259-1221
Homepage URL
Email	y-naruo@sc4.so-net.ne.jp

Sponsor
Institute	Tohoku Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medicine, Osaka City University
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Tel	0666453793
Email	i-gakumu@med.osaka-cu.ac.jp

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	大阪市立大学医学部附属病院（大阪府）、大阪市立総合医療センター（大阪府）、石切生喜病院（大阪府）、淀川キリスト教病院（大阪府）、ベルランド病院（大阪府）、JR大阪鉄道病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 31 Day
Date of IRB	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 03 Day
Last modified on	2020 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018432