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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012114
Receipt No. R000014133
Scientific Title Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer
Date of disclosure of the study information 2013/10/24
Last modified on 2017/11/23

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Basic information
Public title Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer
Acronym Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer
Scientific Title Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Asuka Tsuya
Organization Osaka City General Hospital
Division name Department of clinical oncology
Zip code
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
1st name
Middle name
Last name Asuka Tsuya
Organization Osaka City General Hospital
Division name Department of clinical oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2013 Year 02 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014133

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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