UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007854
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Keio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.