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 |
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Phase 2 Study of Amrubicin for patients with recurrent advanced squamous cell lung cancer after first line treatment.
Japan |
Recurrent squamous cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
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
Safety
Phase II
Response rate
Overall survival
Progression Free Survival
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
Not applicable |
Male and Female
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
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
40
1st name | |
Middle name | |
Last name | Yoshitaro Torii |
Kansai Medical University Hirakata
Hospital
Respiratory medicine
2-3-1, Shinmachi,Hirakata-city,Osaka
072-804-0101
toriiy@hirakata.kmu.ac.jp
1st name | |
Middle name | |
Last name | Yoshitaro Torii |
Kansai Medical University Hirakata
Respiratory medicine
2-3-1, Shinmachi,Hirakata-city,Osaka
072-804-0101
toriiy@hirakata.kmu.ac.jp
Kansai Medical University Hirakata
Hospital
None
Self funding
NO
関西医科大学附属枚方病院
2011 | Year | 09 | Month | 01 | Day |
Unpublished
No longer recruiting
2011 | Year | 05 | Month | 06 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2015 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007419