UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003712 |
|---|---|
| Receipt number | R000004490 |
| Scientific Title | A Phase II Study of Pemetrexed and EGFR-TKI in Patients with Non-Small Cell Lung Cancer After Failing EGFR-TKIs |
| Date of disclosure of the study information | 2010/06/07 |
| Last modified on | 2013/06/04 13:49:59 |
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Basic information
Public title
A Phase II Study of Pemetrexed and EGFR-TKI in Patients with Non-Small Cell Lung Cancer After Failing EGFR-TKIs
Acronym
A Phase II Study of Pemetrexed and EGFR-TKI in Patients with Non-Small Cell Lung Cancer After Failing EGFR-TKIs
Scientific Title
A Phase II Study of Pemetrexed and EGFR-TKI in Patients with Non-Small Cell Lung Cancer After Failing EGFR-TKIs
Scientific Title:Acronym
A Phase II Study of Pemetrexed and EGFR-TKI in Patients with Non-Small Cell Lung Cancer After Failing EGFR-TKIs
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Pemetrexed and EGFR-TKI in Patients with Non-Small Cell Lung Cancer harboring Mutations of EGFR after failing EGFR-TKIs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate (DCR)
Key secondary outcomes
Adverse events, Response Rate, Progression free survival, Overall survival
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
Pemetrexed(500mg/m2) Day1 and
EGFR-TKI Day2-16
q3weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven non-small cell lung cancer.
2)NSCLC harboring mutations of EGFR.
Recurrent disease after treatment with EGFR-TKI(Response: CR, PR, or SD).
3) Stage III, IV
4) Previous chemothrapy with platinum dublet(excluded 75 years or older)
5) Performance Status(ECOG Scale): 0-2.
6) Adequate organ function
7) Life expectancy more than 12 weeks.
8) Written informed consent.
Key exclusion criteria
1) Using NSAIDs regularly.
2) Interstitial pneumonia/lung fibrosis on chest CT.
3) Previous drug allergy
4) History of poorly controlled pleural effusion, pericardial effusion and ascites.
5) Active infection.
6) Current Diarrhea.
7) Ileus or intestinal tract paralysis.
8) Symptomatic brain metastasis.
9) Active concomitant malignancy.
10) History of sever heart disease.
11) History of sever psychological disease.
12) Hoped to be pregnant/nursing.
13) Those judged to be not suitable by the attending physician.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinzoh Kudoh |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruo Yoshimura |
Organization
Department of Respiratory Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3793
Homepage URL
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Osaka Lung Cancer Study 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
大阪市立大学医学部附属病院 呼吸器内科
大阪府立呼吸器・アレルギー医療センター 肺腫瘍内科
大阪市立総合医療センター 臨床腫瘍科
ベルランド病院 呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 04 | Day |
Last modified on
| 2013 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004490
