UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014560 |
|---|---|
| Receipt number | 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 09:28:43 |
* 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 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
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
kkiura@md.okayama-u.ac.jp
Public contact
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/
nnogami@shikoku-cc.go.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016925
