UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000726 |
|---|---|
| Receipt number | 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 16:39:57 |
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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
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
Sponsor or person
Institute
Keio University School of Medicine Division of Pulmonary Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000870
