UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006270 |
|---|---|
| Receipt number | R000007419 |
| Scientific Title | Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2015/09/01 22:58:23 |
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Basic information
Public title
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Acronym
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Scientific Title
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Scientific Title:Acronym
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Region
| Japan |
Condition
Condition
Recurrent squamous cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate Response rate of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
.primary endpoint:
Response rate
.secondary endpoint:
Overall survival
Progression Free Survival
Adverse events
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival
Progression Free Survival
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
Amurubicin (35mg/m2,,i.v.)on Day1,2,3
every three weeks, patients who achieved disease control (response or stable disease) until disease progression, or without unfeasible and unacceptable toxisity
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
squamous cell lung cancer
2) patients with recurrent advanced squamous cell lung cancer after first line treatment
3) Age:at least 20 years of age
4) Eastern Cooperative Oncology Group performance status of 0,1
5) Measurable by RECIST(Ver4.0) criteria
6) Sufficient organ functions
7) written informed consent
Key exclusion criteria
1)Uncontrolled infection or Serious medical complications
2)Massive pleural effusion or ascites after drainage and controrable pleural effusion for 2 weeks
accept controrable pleural effusion with OK-432
3)current or previous treated brain metastasis
4)severe cardiac disease
5)uncontrolled diabetes mellitus
6)receiving anticoagulant drug(except Aspirin under 325mg/day)
7)uncontrolled hypertension
8)current or previous (within the last 1 year) history of GI perforation
9)interstitial pneumonia or lung fibrosis evident on CT
10)history of drug induced interstitial pneumonia
11)patient who has been scheduling operation for examination period
12)treatment history of Amurubicin
13)severe drug allergy
14)active concomitant malignancy
15)severe psychological disease
16)pregnant or lactating women or those who declined contraception
17)those judged to be not suitable by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaro Torii |
Organization
Kansai Medical University Hirakata
Hospital
Division name
Respiratory medicine
Zip code
Address
2-3-1, Shinmachi,Hirakata-city,Osaka
TEL
072-804-0101
toriiy@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaro Torii |
Organization
Kansai Medical University Hirakata
Division name
Respiratory medicine
Zip code
Address
2-3-1, Shinmachi,Hirakata-city,Osaka
TEL
072-804-0101
Homepage URL
toriiy@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata
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
関西医科大学附属枚方病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
| 2011 | Year | 09 | Month | 01 | Day |
Last modified on
| 2015 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007419
