UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000150 |
|---|---|
| Receipt number | R000000216 |
| Scientific Title | A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer |
| Date of disclosure of the study information | 2005/09/09 |
| Last modified on | 2015/08/31 15:51:13 |
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Basic information
Public title
A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Acronym
A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Scientific Title
A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Scientific Title:Acronym
A Phase I/II Study of Amrubicine and Irinotecan in Patients with Advanced Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Small cell lung cancer is one of most chemotherapy-sensitive malignancies. However, the outcome of systemic chemotherapy has been disappointing in extended disease small cell lung cancer (ED-SCLC). This study was conducted to test efficacy and toxicity of the combined regimen of Amrubicine and Irinotecan in ED-SCLC patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: to determine the maximum tolerated dose and the recommended dose for phase II study
Phase II: to confirm the efficacy and toxicity of the combined therapy at the recommended dose
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
The Amrubicine is administered on day 1-3, and the Irinotecan is administered on day 1 and 8 every three 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with histological or cytological confirmation of SCLC
2) Extended disease or Limited disease with malignant effusion
3) Patients previously untreated with chemotherapy
4) At least 2 Months of Life expectancy
5) ECOG Performance Status (PS) 0-1
6) The presence of measurable region
7) Adequate organ function
8) 20 years or older to 70 years
9) Written informed consent
Key exclusion criteria
Presence of pulmonary fibrosis with symptoms or apparent abnormality on chest X-rays,
2) Acute inflammation, infection
3) Massive pleural effusion or pericardial effusion
4) Uncontrollable diabetes mellitus
5) ileus, intestinal paralysis, diarrhea
6) Symptomatic brain metastasis
7) Severe heart disease
8) Pregnancy
9) Severe drug allergies
10) Prior radiotherapy to the chest or the pelvis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Nakanishi |
Organization
Kyushu University Hospital
Division name
Research institute for the disease of the chest
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5378
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
Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
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 | 09 | Month | 09 | 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=24379211
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
| 2003 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | 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
| 2005 | Year | 09 | Month | 09 | 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=R000000216
