UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006370 |
|---|---|
| Receipt number | R000007096 |
| Scientific Title | Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer |
| Date of disclosure of the study information | 2011/09/21 |
| Last modified on | 2013/06/23 16:04:40 |
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Basic information
Public title
Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer
Acronym
Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer
Scientific Title
Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer
Scientific Title:Acronym
Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer
Region
| Japan |
Condition
Condition
Squamous Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Amrubicin in patients with previously treated Squamous Cell Lung Cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease Control Rate (DCR)
Key secondary outcomes
Overall survival, Progression-free survival, Response rate, Safty
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
Amrubicin is administered intravenously at a dose of 35 mg/m2/day on days 1-3 every 3 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven squamous cell lung cancer.
"2) Patients who have previously treated with chemotherapy.
"
3) Patient who has at least one or more measurable lesion by RECIST criteria (Ver.1.1).
"4) More than 28 days after last chemotherapy (more than 14 days after the last gefitinib) and more than 28 days rest period after radiation.
"
5) ECOG performance status (PS): 0-2
6) Patients aged of 20 to 74 years.
"7) Sufficient function of main organ and bone marrow filled the following criteria:
"
Leukocyte counts, 4,000/mm3 or over and 12,000/mm3 or under
Neutrophil counts, 2,000/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0g/dL or over
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
Arterial oxygen partial pressure 60 Torr or over.
Adequate heart function by ECG.
LVEF (echocardiography), 60% or over.
8) Written informed consent from the patients.
Key exclusion criteria
1) Patients who have previously treated with chemotherapy containing amrubicin.
2) Patients with symptomatic brain metastasis.
3) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites.
4) Patients with active severe infections
5) Patients with double cancer within 5 years.
6) Patients with active interstitial pneumonia recognized by chest X-ray.
7) Patients with serious drug allergic reactions.
8) Patients with active concomitant pregnancy.
9) Patients with cardiac infarction or necessary cardiac function abnormality of the treatment.
10) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2.
11) Patients with active gastric or duodenal ulcer
12) Inappropriate patients for this study judged by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St.Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Handa |
Organization
St.Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St.Marianna University 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 21 | 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
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 23 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 23 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 19 | Day |
Last modified on
| 2013 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007096
