UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011696 |
|---|---|
| Receipt number | R000013674 |
| Scientific Title | A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2013/09/11 |
| Last modified on | 2015/10/31 21:20:21 |
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Basic information
Public title
A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer
Acronym
A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer
Scientific Title
A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym
A Phase II Trial of Abraxane in Patients with Advanced Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non-small cell carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate for efficacy and toxicities of Abraxane 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, 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
Abraxane (100mg/m2) is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4 weeks.
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 advanced non-small-cell lung cancer
2) Patients with NSCLC (advanced stage or recurrent disease) previously treated with chemotherapy
3) Performamne status of 0 or 2
4) 20 years of age or older
5) The presence of mesurable lesions by RECIST
6) Cases survival of 8 weekss or more is expected
7) Written informed consents
8) Adequate organ funcion
White blood cell count >= 3,000 /mm3
Neutrophil count >= 1,500 /mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
AST and ALT x 2.5 of upper limit of normal (ULN) or less
Total bilirubin <or= 1.5 mg/dL
Serum creatinine x 1.5 of upper limit of normal (ULN) or less
Pao2 >= 60 torr or SPo2 >= 95%
9) Interval from previous chest radiotherapy: more than 12 weeks after the last irradiation to lung (paliative radiation to bone is excluded)
10) Interval from previous treated with intrapleural therapy for malignant pleural effusion: more than 1 week
11) Interval from previous chemotherapy: more than 1 week
Key exclusion criteria
1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray
2) Severe concurrent disease (Ischemic heart disease requiring treatment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes)
3) Severe infection
4) History of active double cancer within 5 years prior to the study
5) Sympyomatic brain metastasis
6) Massive pleural effusion requiring treatment
7) Patients who are pregnant,considering pregnancy oractaing
8) Other conditions not suitable forthis study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kageaki Taima |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Cardiology, Respiratory Medicine and Nephrology
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562 Japan
TEL
0172-39-5057
taima0305@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Tanaka |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Cardiology, Respiratory Medicine and Nephrology
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562 Japan
TEL
0172-39-5057
Homepage URL
xyghx335@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
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
弘前大学病院（青森県），弘前中央病院（青森県），国立病院機構弘前病院（青森県）
八戸市立市民病院（青森県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 11 | 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 | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2015 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013674
