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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006641
Receipt No. R000007855
Scientific Title A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
Date of disclosure of the study information 2011/11/07
Last modified on 2011/11/01

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Basic information
Public title A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
Acronym A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
Scientific Title A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
Scientific Title:Acronym A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of Docetaxel and Bevacizumab in a phase II clinical study for patients previously treated advanced non-squamous non small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Safety, Progression Free 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 Docetaxel+Bevacizumab
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.Histologically or cytologically confirmed non-squamous non-small cell lung cancer
2.Stage 3/4 unresectable or unsuitable for radical irradiation
3.Relapsed or progressed to one prior chemotherapy
4. The prior chemotherapy is only one regimen.
5. With measurable disease (based on RECIST ver1.1)
6. Age >= 20
7. Performance status (ECOG) : 0 or 1, 2
8. Adequate function of vital organs as following;(within two weeks before registration)
Neutrophils >= 1,500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 8.5 g/dL
AST/ALT <= 2.5ULN
Total bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
PaO2 >= 60mmHg or SpO2 >= 92%
9. A life expectancy of more than 3 months
10. Written informed consent before initiation of study-related procedures
Key exclusion criteria 1. No prior treatment with Docetaxel and Bevacizumab
2.History of hemoptysis with 2.5mL per time or more.
3.Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
4.massive pleural or pericardial effusion.
5. CNS metastasis
6. Patients with a concomitant or prior invasive malignancy who have had any evidence of the disease within the last 5 years
7. Patients with severe complications
Unstable angina. cardiovascular disease, severe heart disease, heart failure within 3month.
Uncontrollable diabetes mellitus and hypertension
Active infection
8. In pregnancy, during breast feeding, or possibility of pregnancy.
9.The past history of severe allergic reactions
10. psychiatric patients
11. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 41

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Tamura
Organization Kinki University School of Medicine, Nara Hospital
Division name Department of Medical Oncology
Zip code
Address 1248-1,Otoda-cho,ikoma-shi,Nara,Japan
TEL 0743770880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yusaku Akashi
Organization Kinki University Faculty of Medicine, Nara Hospital
Division name Department of Medical Oncology
Zip code
Address 1248-1,Otoda-cho,ikoma-shi,Nara,Japan
TEL 0743770880
Homepage URL
Email

Sponsor
Institute Kinki University Faculty of Medicine, Nara Hospital
Institute
Department

Funding Source
Organization No Funding Source
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
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 近畿大学医学部奈良病院(奈良県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 07 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
2011 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2011 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
2011 Year 11 Month 01 Day
Last modified on
2011 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007855

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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