UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000071 |
|---|---|
| Receipt number | R000000118 |
| Scientific Title | Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy |
| Date of disclosure of the study information | 2005/08/22 |
| Last modified on | 2015/08/31 15:27:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
Acronym
Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
Scientific Title
Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
Scientific Title:Acronym
Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
Region
| Japan |
Condition
Condition
All patients had histologocally or cytologically confirmed locally advanced (non-irradiated) or metastatic NSCLC, with failure of platinum-based chemotherapy (exception for UFT and gefitinib).
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of amrubicin in patients with non-small cell lung cancer who had failed platinum-based chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate (according to RECIST criteria)
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 was given at 40mg/m2 intravenously over 5 minutes 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 histologocally or cytologically confirmed locally advanced (non-irradiated) or metastatic NSCLC, with failure of platinum-based chemotherapy (exception for UFT and gefitinib). Before study entry, at least 4 weeks must have elapsed since any prior chemotherapy or radiotherapy. Patients had to have measurable disease, a Eastern Cooporative Oncology Group (ECOG) performance status 0 or 1, 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, severe superior vena cava syndrome, uncontrollable diabetes mellitus, severe infection, or active peptic ulcer. Patients who have prior receive amrubicin and other anthracycline drugs were excluded, too.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Uejima |
Organization
Izumisano Municipal Hospital, Rinku General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
2-23 Rinkuoraikita, Izumisano, Osaka, 598-0048, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
| 2005 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=19884859
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
Completed
Date of protocol fixation
| 2004 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000118
