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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000726
Receipt No. R000000870
Scientific Title Phase I/II trial of Amrubicin Hydrochloride in 3rd line treatment for patients with Recurrent Non-small cell Lung cancer [AMNOL-3rd]
Date of disclosure of the study information 2007/05/28
Last modified on 2015/07/22

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Basic information
Public title Phase I/II trial of Amrubicin Hydrochloride in 3rd line treatment for patients with Recurrent Non-small cell Lung cancer [AMNOL-3rd]
Acronym AMNOL-3rd
Scientific Title Phase I/II trial of Amrubicin Hydrochloride in 3rd line treatment for patients with Recurrent Non-small cell Lung cancer [AMNOL-3rd]
Scientific Title:Acronym AMNOL-3rd
Region
Japan

Condition
Condition Previously treated non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the maximumm tolerated dose (MTD) and recommended dose (RD) of Amrubicin hydrochloride for previously treated non-small cell lung cancer patients.
To investigate safety and efficacy of recomended dose Amrubicin hydrochloride for them.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I;To verify MTD and RD
Phase II;
primary endpoint: disease control rate, response rate
secondary endpoint: overall survival(OS), progression free survival (PFS),safety
Key secondary outcomes

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 hydrochloride is given at previously decided dose intraveniously for three consecutive days 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 All patients had histologically or cytologically confirmed stage IIIB/IV NSCLC, with failure of prior chemotherapy (two regimen). Before study entry, at least 4 weeks must have elapsed since any prior chemotherapy or radiotherapy. Patients had to have measurable disease, a Eastern Cooperative Oncology Group (ECOG) performance status 0 ,1 or 2, and be aged between 20 and 74 years. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
Key exclusion criteria The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion, pericardial effusion, or ascites, pregnancy, lactation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, or severe infection. Patients who have already received amrubicin and other anthracycline drugs were excluded, too.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akitoshi Ishizaka
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address 35 Shinomachi-Sinjuku
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine Division of Pulmonary Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine Division of Pulmonary Medicine
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
2007 Year 05 Month 28 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
2006 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 05 Month 28 Day
Last modified on
2015 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000870

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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