UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010002 |
|---|---|
| Receipt number | R000007786 |
| Scientific Title | Phase II study of pemetrexed maintenance with or without bevacizumab after a first line treatment chemotherapy with bevacizumab-carboplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2013/02/08 |
| Last modified on | 2016/06/10 12:12:21 |
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Basic information
Public title
Phase II study of pemetrexed maintenance with or without bevacizumab after a first line treatment chemotherapy with bevacizumab-carboplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer
Acronym
BPOP
Scientific Title
Phase II study of pemetrexed maintenance with or without bevacizumab after a first line treatment chemotherapy with bevacizumab-carboplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer
Scientific Title:Acronym
BPOP
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of study is the efficacy and safety of pemetrexed maintenance therapy with or without bevacizumab after completion of bevacizumab + carboplatin + pemetrexed chemotherapy without disease progression in Patients with advanced, metastatic or recurrent NSCLC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival for 9 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2011/07/01-2014/06/01
Interventions/Control_2
bevacizumab
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
Advanced, metastatic or recurrent NSCLC
PS(ECOG) 0-1
Additional eligibility criteria included
Adequate function of the bone marrow, liver and kidney.
All patients provided written informed consent
Key exclusion criteria
interstitial lung disease
history of hemoptysis
myocardial infarction,unstable angina, stroke, transient ischemic attack
significant vascular disease
bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
hypertension or history of hypertensive crisis or encephalopathy; known CNS disease, except brain metastases treated with radiotherapy
pregnancy
abdominal fistula, or gastrointestinal perforation poorly controlled
active ulcer
known hypersensitivity to drug
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shun Matsuura |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Hamamatsu 431-3192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
TEL
053-435-2263
Homepage URL
Sponsor or person
Institute
Internal Medicine 2, Hamamatsu University School of Medicine.
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
| 2013 | Year | 02 | Month | 08 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 08 | Day |
Last modified on
| 2016 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007786
