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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010737
Receipt No. R000012543
Scientific Title Phase II Study for Efficacy and Safety of nab-paclitaxel for Previously Treated Advanced Non-small Cell Lung Cancer
Date of disclosure of the study information 2013/05/16
Last modified on 2019/04/12

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Basic information
Public title Phase II Study for Efficacy and Safety of nab-paclitaxel for Previously Treated Advanced Non-small Cell Lung Cancer
Acronym Phase II study of nab-PTX for previously treated adnvaced NSCLC
Scientific Title Phase II Study for Efficacy and Safety of nab-paclitaxel for Previously Treated Advanced Non-small Cell Lung Cancer
Scientific Title:Acronym Phase II study of nab-PTX for previously treated adnvaced NSCLC
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate for efficacy and toxicities of nab-paclitaxel monotherapy for previously treated advanced 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 progression-free survival, overall survival, toxicities, number of cycles

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 administration of nab-paclitaxel 100mg/m^2 weekly (day1, 8, 15; 3 weeks for each cycle) until disease progression or unacceptable toxicities
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Definitively diagnosed with having previously treated advanced non-small cell lung cancer by the specimens histologically or cytologically.
2) Age of more than 18 years-old
3) PS (ECOG); 0-2
4) with the status of previously being treated with standard chemotherapy: previously treated with docetaxel for squamous cell carcinoma; previously treated with both docetaxel and pemetrexed for non-squamous cell carcinoma; or intraindication for docetaxel or pemetrexed
3) With adequate organ function of bone marrow reserve, liver, and kidney.
(1) neutrophil count => 1,500/mm^3
(2) platelet => 100,000/mm^3
(3) AST/ALT < 2.5 times less than ULN
(4) hemoglobin => 9.0g/dL
(5) serum creatinine <= 1.5mg/dL
(6) SpO2 (room air) more than 92%
4) With the status of below previous treatment at the time of beginning of chemotherapy.
(1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation
(2) Surgical procedure, including pleurodesis or pleural drainage
* more than 8 weeks with lobectomy
* more than 4 weeks without lobectomy, including exploratory thoracotomy
* more than 2 weeks after completing procedure (pleurodesis or pleural drainage)
5) With expected prognosis more than 12 weeks
6) With written informed consent
Key exclusion criteria 1) Previously treated with paclitaxel
2) With uncontrolled brain metastasis
3) With clinically active infection
4) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes)
5) With uncontrolled pleural effusion
6) With active other organ cancer
7) With the history of severe drug allergy
8) With the history of hypersensivity for paclitaxel, albumin-containing agents
9) With uncontrolled digestive ulcer
10) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 55

Research contact person
Name of lead principal investigator
1st name Yukio
Middle name
Last name Hosomi
Organization Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo Tokyo
TEL 03-3823-2101
Email yhosomi@cick.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Okuma
Organization Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo Tokyo
TEL 03-3823-2101
Homepage URL
Email y-okuma@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
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 Ethics committee of Tokyo Metropolitan Komagome Hospital
Address Honkomagome 3-18-22, Bunkyo, Tokyo
Tel 03-3823-2101
Email rinri@cick.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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 16 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 22
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 Main results already published
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
2013 Year 03 Month 18 Day
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 16 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012543

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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