UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012972 |
|---|---|
| Receipt number | R000014411 |
| Scientific Title | A phase II study of nab-paclitaxel for pretreated non-small cell lung cancer |
| Date of disclosure of the study information | 2014/01/27 |
| Last modified on | 2017/07/11 09:39:20 |
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Basic information
Public title
A phase II study of nab-paclitaxel for
pretreated non-small cell lung cancer
Acronym
A phase II study of nab-paclitaxel for
pretreated non-small cell lung cancer
Scientific Title
A phase II study of nab-paclitaxel for
pretreated non-small cell lung cancer
Scientific Title:Acronym
A phase II study of nab-paclitaxel for
pretreated 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 evaluate the 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, frequency of adverse events
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 21-28 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 non-small cell lung cancer
2)unresectable disease
3)The presence of measureable lesions
4)Age of 20 years or older
5)Life expectancy more than 12weeks
6)ECOG Perfomance status 0-2
7) Previous 1-2 regimen chemotherapy consisting of platinum
8)oral UFT for adjuvant chemotherapy do not count as 1 regimen
9)EGFR-TKI or ALK inhibiter do not count as 1 regimen
10)Interval of more than 28 days from the last chemotherapy or radiotherapy
11)preserved organ's function
WBC>=3,000/mm3
Hemoglobin>= 9.0g/dl
Platelet count>=100,000/mm3
Total serum bilirubin <=1.5 mg/dl
GOT/GPT <100 IU/l
Serum creatinine <=1.5mg/dl
12)Acquisition of written informed consent
Key exclusion criteria
1)patients previously treated with paclitaxel derivative drugs
2)Anamnesis of hypersensitivity to albumin
3)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case)
4)evident pericardial effusion
5)serious complications below
uncontrollable angina pectoris, myocardial infarction within 3 months or heart failure
uncontrollable diabetes
uncontrollable hypertension
severe infection
6)pulmonary fibrosis or interstitial pneumonitis evident
7)HB and HC virus carrier
8)now pregnant or lactation
9)difficult to perform or continue of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo Yamada |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
2-3-2,Nakao, Asahi-ku, Yokohama-city, Kanagawa, Japan
TEL
045-520-2222
yamadak@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Murakami |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
2-3-2,Nakao, Asahi-ku, Yokohama-city, Kanagawa, Japan
TEL
045-520-2222
Homepage URL
murakamis@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
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
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
| 2014 | Year | 01 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 19 | 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
| 2014 | Year | 01 | Month | 27 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014411
