UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011823 |
|---|---|
| Receipt number | R000013821 |
| Scientific Title | Phase II study of more than second-line Nab-PTX for advanced non-small cell lung cancer which is previously treated with chemotherapy |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2017/03/24 12:52:26 |
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Basic information
Public title
Phase II study of more than second-line Nab-PTX for advanced non-small cell lung cancer which is previously treated with chemotherapy
Acronym
Phase II Study of more than 2nd line Nab-PTX for NSCLC
Scientific Title
Phase II study of more than second-line Nab-PTX for advanced non-small cell lung cancer which is previously treated with chemotherapy
Scientific Title:Acronym
Phase II Study of more than 2nd line Nab-PTX for NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of Nab-PTX as more than 2nd-line therapy in patients with stage IIIB/IV 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
disease control rate, toxicities, progression-free survival, overall survival
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 at the dose of 100mg/m2 (day 1, 8, 15) is administered every 4 weeks. Treatment can be continued unless PD or toxicity that is not tolerable is found.
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) Definitively diagnosed with non-small cell lung cancer by the specimens histologically or cytologically.
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV
3) Prior chemotherapy is 1 or 2 regimen. Regimen count is defined as follows
a. Exclude EGFR-TKI and ALK inhibitor
b. Exclude continuation maintenance, include switch maintenance
c. Include adjuvant chemotherapy
4) Age of 20 to 79 years
5) Without active cancer other than NSCLC
6) At least one measurable lesion
7) With adequate organ function
a. neutrophil count => 1,500/mm^3
b. platelet => 100,000/mm^3
c. hemoglobin => 9.0g/dL
d. AST/ALT < 2.5 times less than ULN
e. T.Bil <= 1.5mg/dL
f. serum creatinine <= 1.5mg/dL
g. ECG: without clinically problematic abnorbomalities
h. Peripheral neuropathy <= Grade 1
8) Life expectancy of at least 3 months
9) ECOG performance status 0 or 1
10) With written informed consent
Key exclusion criteria
1) Symptomatic brain metastasis
2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
3) With active double cancer or multicentric cancer
4) The peripheral sense neuropathy is Grade2 or more by CTCAE at registration.
5) Treated with radiotherapy within the past four weeks.
6) With a history of the treatment with Paclitaxel.
7) With clinically important complications.
8) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem
9) With pleural effusion or pericardial effusion accumulates which need drainage
10) With the history of hypersensivity for paclitaxel or albumin
11) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe.
12) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Tomizawa |
Organization
Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2854, Shibukawa-shi, Gunma, Japan
TEL
0279-23-3030
ytomizawa@netnngh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Tomizawa |
Organization
Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2854, Shibukawa-shi, Gunma, Japan
TEL
0279-23-3030
Homepage URL
ytomizawa@netnngh.hosp.go.jp
Sponsor or person
Institute
Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
Institute
Department
Personal name
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
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
| 2013 | Year | 09 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2017 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013821
