UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007854 |
|---|---|
| Receipt number | R000009022 |
| Scientific Title | Phase 2 study of Bevacizumab Beyond Progression treatment in patients with advanced non-squamous non-small-cell Lung cancer |
| Date of disclosure of the study information | 2012/04/30 |
| Last modified on | 2012/04/29 21:56:49 |
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Basic information
Public title
Phase 2 study of Bevacizumab Beyond Progression treatment in patients with advanced non-squamous non-small-cell Lung cancer
Acronym
BBPL study
Scientific Title
Phase 2 study of Bevacizumab Beyond Progression treatment in patients with advanced non-squamous non-small-cell Lung cancer
Scientific Title:Acronym
BBPL study
Region
| Japan |
Condition
Condition
advanced non-squamous non-small-cell Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study was conducted a phase 2 trial as second line therapy to evaluate the efficacy and safety of Docetaxel plus Bevacizumab for patients with advanced non-squamous non-small-cell Lung cancer who treated with Platinum doublet plus Bevacizumab and maintenance therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
PFS of secondary treatment
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
Patients received cisplatin 75 mg/m2 or carboplatin AUC 5 and pemetrexed 500 mg/m2, bevacizumab 15 mg/kg on day1 at 21-day intervals for 4-6 cycles.Patients who respond induction thepary move into maintenace therapy.Maintenance therapy is bevacizumab 15 mg/kg or bevacizumab 5 mg/kg plus pemetrexed 500 mg/m2 on day1 at 21-day intervals until progression disease.After progressive disease, patients recieved bevacizumab 15 mg/kg and docetaxel 60 mg/m2 on day1 at 21-day intervals until pogressive disease.
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)non small cell carcinoma and non squamous cell carcinoma
(2)stage3B/4 or postoperative recurrence
(3)no pretreatment patients
(4)PS(ECOG)0-1
(5)patients have measurable lesion based on RECIST(ver1.1)
(6)standard laboratory tests
(7)patients don't have recent major surgery, radiation therapy, and so on
(8)patients agreed this clinical study
Key exclusion criteria
(1)symptoms due to brain metastasis
(2)hemoptysis
(3)significant hemosputum
(4)radiation therapy to chest region
(5)significant infectious disease
(6)severe conplication
(7)uncontrollable acsites, plueral effusion, cardiac effusion
(8)active multiple cancer
(9)severe drug allergy
(10)unnable to administer vitamin B12.reject to Vitamin B12
(11)interstitial pneumoniae or pulmonary fibrosis
(12)uncontrollable hypertension
(13)uncontrollable gastrointestinal tract ulcer
(14)perforation of the digestive tract or experimental operation
(15)doctors estimated innadequated
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenzo Soejima |
Organization
Keio University, School of Medicine
Division name
Division of Pulmonary Medicine, Dept. of Internal Medicine
Zip code
Address
35 Shinanomachi,Shinjuku-ku,Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Naoki |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
Address
35 Shinanomachi,Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 04 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 04 | Month | 28 | Day |
Last modified on
| 2012 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009022
