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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014560
Receipt No. R000016925
Scientific Title Phase 1/2 study of triple combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for chemotherapy-naïve stageIIIB/IV non- squamous non-small-cell lung cancer (TORG1424/OLCSG1402)
Date of disclosure of the study information 2014/07/30
Last modified on 2019/04/24

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Basic information
Public title Phase 1/2 study of triple combination chemotherapy with Carboplatin,
nab-Paclitaxel, and Bevacizumab for chemotherapy-naïve stageIIIB/IV non-
squamous non-small-cell lung cancer (TORG1424/OLCSG1402)
Acronym CARboplatin, Nab-paclitaxel and AVAstin
for non-small cell Lung cancer(CARNAVAL)
(TORG1424/OLCSG1402)
Scientific Title Phase 1/2 study of triple combination chemotherapy with Carboplatin,
nab-Paclitaxel, and Bevacizumab for chemotherapy-naïve stageIIIB/IV non-
squamous non-small-cell lung cancer (TORG1424/OLCSG1402)
Scientific Title:Acronym CARboplatin, Nab-paclitaxel and AVAstin
for non-small cell Lung cancer(CARNAVAL)
(TORG1424/OLCSG1402)
Region
Japan

Condition
Condition Advanced stage IIIB/IV non-squamous non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

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

Assessment
Primary outcomes Phase 1:Decision of recommend dose and schedule
Phase 2: Response Rate
Key secondary outcomes Overall survival(OS)
Progression-free survival(PFS)
Safety

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 + Bevacizmab
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 IIIB or stage IV without any indications for radiotherapy
3) No prior chemotherapy
4) Non active EGFR and ALK mutations
5) Have measurable lesions
6) Aged >=20 at the time of registration
7) ECOG performance status 0-1
8) Adequate organ function
9) Estimated life expectancy at least 12 weeks
10) Written informed consent
Key exclusion criteria 1) Symptomatic brain metastasis.
2) Current history of hemoptysis.
3) History of hypersensitivity for therapeutic agent or albumin products
4) With grade2 or more neuropathy
5) Uncontrolled ascites, pleural effusion or cardiac effusion.
6) Within 2 weeks after palliative radiotherapy
7) Within 4 weeks after operation
8) Active double malignancies
9) Fever over 38C
10) serious medical complications
11) Receiving anticoagulant drug (325mg and less aspirin is possible)
12) Pregnancy, breastfeeding or suspected of being pregnant
13) HBs positive patient
14) Others judged by attending physician
Target sample size 55

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Kiura
Organization Katsuyuki Kiura
Division name Department of Allergy and Respiratory
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558
TEL (086)223-7151
Email kkiura@md.okayama-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naoyuki Nogami
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of thoracic oncology
Zip code
Address 160 Kou Minamiumemoto-machi, Matsuyama, Ehime 791-0280
TEL (089)999-1111
Homepage URL http://www.torg.or.jp/
Email nnogami@shikoku-cc.go.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Taiho Pharmaceutical CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 07 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 Completed
Date of protocol fixation
2014 Year 06 Month 02 Day
Date of IRB
2014 Year 09 Month 22 Day
Anticipated trial start date
2014 Year 10 Month 09 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 15 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016925

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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