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Recruitment status Terminated
Unique ID issued by UMIN UMIN000006370
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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