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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016932
Receipt No. R000019656
Scientific Title Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.
Date of disclosure of the study information 2015/03/26
Last modified on 2019/09/30

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Basic information
Public title Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.
Acronym Phase II clinical study of nab-PTX for patients with recurrent NSCLC
Scientific Title Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.
Scientific Title:Acronym Phase II clinical study of nab-PTX for patients with recurrent NSCLC
Region
Japan

Condition
Condition advanced non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effectivity and safty of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Overall survival/ Objective response rate/ Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm A nab-Paclitaxel (100mg/m2) day 1,8,15 : every 4 weeks
Interventions/Control_2 Arm B nab-Paclitaxel (70mg/m2) day 1,8,15 : every 4 weeks
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) Clinical stage IIIB, IV or post-operative recurrence.
3) Age 20 years or older.
4) ECOG Performance Status (PS) 0 to 1.
5) At least one mesurable lesion according to RECIST version 1.1.
6) Patients treated with at least one platinum regimens
7) With adequate organ function, neutrophil count over 1,500 / mm3, hemoglobin concentration over 9.0 g / dL, platelet count over 100,000 / mL), kidney (creatinine within 1.5 mg / dL), liver (AST/ALT within 2.5 times less than ULN, total bilirubin within 1.5 mg/dL), peripheral neuropathy within Grade1, PaO2
over 60 Torr or SpO2 over 94.
8) Life expectancy of more than three months.
9) Provided written consent in person for participation in this study.

Key exclusion criteria 1) Patient with previous treatment by paclitaxel.
2) Patient receiving chemotherapies less than 4 weeks or EGFR-TKI within two weeks.
3) Patient receiving definitive radiotherapy for less than 6 weeks or local palliative radiotherapy for less than 2 weeks.
4) Patient with symptomatic brain metastasis.
5) Patient with need of chest drainage for pleural effusion.
6) Active infection.
7) Patient with severe complications.
8) Patient having autoimmune disease to need treatment by the immunosuppressive drug.
9) Patient with active multiple cancers.
10) Female Patient in or having a chance or planning of pregnancy or breast feeding. Male patient in planning to impregnate.
11) History of sever psychological disease.
12) Administering steroid.
13) Any patients judged by the investigator to be unfit to participate in the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kaoru
Middle name
Last name Kubota
Organization Nippon Medical School Hospital
Division name Cancer center and Department of Pulmonary Medicine and Oncology
Zip code 1138603
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email kkubota@nms.ac.jp

Public contact
Name of contact person
1st name Kaoru
Middle name
Last name Kubota
Organization Nippon Medical School Hospital
Division name Cancer center and Department of Pulmonary Medicine and Oncology
Zip code 113
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email kkubota@nms.ac.jp

Sponsor
Institute The Japan-Multinational Trial Organization (JMTO)
Institute
Department

Funding Source
Organization Taiho Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization The Japan-Multinational Trial Organization
Address 2-14-10 Marunouchi Naka-ku Nagoya City, Aichi, Japan
Tel 052-218-3301
Email jmto-adm@jmto.org

Secondary IDs
Secondary IDs YES
Study ID_1 JMTO LC14-01
Org. issuing International ID_1 The Japan-Multinational Trial Organization (JMTO)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions JMTO所属医療機関

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 26 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 81
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
2015 Year 01 Month 26 Day
Date of IRB
2014 Year 10 Month 24 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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