UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003215 |
|---|---|
| Receipt number | R000003807 |
| Scientific Title | A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations |
| Date of disclosure of the study information | 2010/02/20 |
| Last modified on | 2010/02/19 20:22:20 |
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Basic information
Public title
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Acronym
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Scientific Title
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Scientific Title:Acronym
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Objective of the study is to investigate the efficacy and safety of Erlotinib for patients previously treated with chemotherapy career of 1-3 regimens Non-small cell Lung Cancer with EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
rseponse rate
Key secondary outcomes
Evaluation of safety, Progression free survival, Median survival time
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
Single agent chemotherapy with Erlotinib
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients having EGFR mutation, stage IIIB, IV or relapsed NSCLC previously treated with 1-3 regimens of chemotherapy.
2) Patients who has measurable lesion.
3) ECOG performance status (PS): 1 or less
4) Patients aged 20 years or older.
5) Sufficient function of main organ and bone marrow filled the following criteria.
WBC >=3,000/mm3
Neu >=1,500/mm3
PLT >=10x104/mm3
Hb >=9.0g/dL
sCr <=1.5mg/dL
GOT,GPT x 2.5 of upper limit of normal or less
T-Bil <=1.5mg/dL
PaO2 >=70torr
6) Patients who are considered to survive for more than 3 months.
7) Patients providing written informed consent.
Key exclusion criteria
1)Active infection (fever)
2)Cases with past history of EGFR-TKI
3)Presence of active interstitial lung disease or pulmonary fibrosis
4)Patients with massive pleural or prericardial effusion or ascites
5)Patients with uncontrollable complications
6)Patients with active double cancer
7)Pregnancy or lactation.
8)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Sakakibara |
Organization
Fujita Health Universty Hospital
Division name
Division of Respirology and Allergology
Zip code
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Sakakibara, Yuji Saito, Yoshitaka Totani |
Organization
Fujita Health Universty Hospital
Division name
Division of Respirology and Allergology
Zip code
Address
TEL
0562-93-9241
Homepage URL
Sponsor or person
Institute
Fujita Health Universty Hospital Division of Respirology and Allergology
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
| 2010 | Year | 02 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 19 | Day |
Last modified on
| 2010 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003807
