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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013201
Receipt No. R000014968
Scientific Title Phase I/II trial of nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy for patients with advanced Non-Squamous Non-Small Cell Lung Cancer.
Date of disclosure of the study information 2014/02/19
Last modified on 2021/03/31

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Basic information
Public title Phase I/II trial of nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy for patients with advanced Non-Squamous Non-Small Cell Lung Cancer.
Acronym Phase I/II trial of nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy for patients with advanced Non-Squamous Non-Small Cell Lung Cancer.
Scientific Title Phase I/II trial of nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy for patients with advanced Non-Squamous Non-Small Cell Lung Cancer.
Scientific Title:Acronym Phase I/II trial of nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy for patients with advanced Non-Squamous Non-Small Cell Lung Cancer.
Region
Japan

Condition
Condition Advanced Non-Squamous Non-Small Cell Lung Cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of nab-Paclitaxel, Carboplatin,plus Bevacizumab chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes PhaseI:Dose Limiting Toxicity(DLT),Minimal Tolerated Dose(MTD),Recommended Dose(RD)
PhaseII:Objective Response Rate(ORR)
Key secondary outcomes PhaseI:Safety,Objective Response Rate(ORR),Progression Free Survival(PFS),Overall Survival(OS)

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 Nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy
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
75 years-old >
Gender Male and Female
Key inclusion criteria The patients histologically or cytologically diagnosed advanced Non-Squamous Non-Small Cell Lung Cancer.
ECOG Performanse status 0-1
Key exclusion criteria The patients who have brain metastasis and have symptom or need therapy.
The patients who have hemoptysis.
Target sample size 61

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishio
Organization Cancer Institute Hospital of JFCR
Division name Department of Thoracic Medical oncology
Zip code
Address 3-8-31 Ariake Koto-ku Tokyo Japan
TEL 03-3520-0111
Email mnishio@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Horiike
Organization Cancer Institute Hospital of JFCR
Division name Department of Thoracic Medical oncology
Zip code
Address 3-8-31 Ariake Koto-ku Tokyo Japan
TEL 03-3520-0111
Homepage URL
Email atsushi.horiike@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital of JFCR
Institute
Department

Funding Source
Organization Cancer Institute Hospital of JFCR
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 19 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 Completed
Date of protocol fixation
2013 Year 10 Month 16 Day
Date of IRB
2014 Year 02 Month 19 Day
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2017 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 05 Month 29 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 19 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014968

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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