UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016932 |
|---|---|
| Receipt number | R000019656 |
| Scientific Title | Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2015/03/26 |
| Last modified on | 2023/04/01 23:40:37 |
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Basic information
Public title
Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.
Acronym
Phase II clinical study of nab-PTX for patients with recurrent NSCLC
Scientific Title
Phase II clinical study of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer.
Scientific Title:Acronym
Phase II clinical study of nab-PTX for patients with recurrent NSCLC
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectivity and safty of nab-paclitaxel for patients with recurrent advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Overall survival/ Objective response rate/ Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm A nab-Paclitaxel (100mg/m2) day 1,8,15 : every 4 weeks
Interventions/Control_2
Arm B nab-Paclitaxel (70mg/m2) day 1,8,15 : every 4 weeks
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-small cell lung cancer.
2) Clinical stage IIIB, IV or post-operative recurrence.
3) Age 20 years or older.
4) ECOG Performance Status (PS) 0 to 1.
5) At least one mesurable lesion according to RECIST version 1.1.
6) Patients treated with at least one platinum regimens
7) With adequate organ function, neutrophil count over 1,500 / mm3, hemoglobin concentration over 9.0 g / dL, platelet count over 100,000 / mL), kidney (creatinine within 1.5 mg / dL), liver (AST/ALT within 2.5 times less than ULN, total bilirubin within 1.5 mg/dL), peripheral neuropathy within Grade1, PaO2
over 60 Torr or SpO2 over 94.
8) Life expectancy of more than three months.
9) Provided written consent in person for participation in this study.
Key exclusion criteria
1) Patient with previous treatment by paclitaxel.
2) Patient receiving chemotherapies less than 4 weeks or EGFR-TKI within two weeks.
3) Patient receiving definitive radiotherapy for less than 6 weeks or local palliative radiotherapy for less than 2 weeks.
4) Patient with symptomatic brain metastasis.
5) Patient with need of chest drainage for pleural effusion.
6) Active infection.
7) Patient with severe complications.
8) Patient having autoimmune disease to need treatment by the immunosuppressive drug.
9) Patient with active multiple cancers.
10) Female Patient in or having a chance or planning of pregnancy or breast feeding. Male patient in planning to impregnate.
11) History of sever psychological disease.
12) Administering steroid.
13) Any patients judged by the investigator to be unfit to participate in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Kubota |
Organization
Nippon Medical School Hospital
Division name
Cancer center and Department of Pulmonary Medicine and Oncology
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
kkubota@nms.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Kubota |
Organization
Nippon Medical School Hospital
Division name
Cancer center and Department of Pulmonary Medicine and Oncology
Zip code
113
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
kkubota@nms.ac.jp
Sponsor or person
Institute
The Japan-Multinational Trial Organization (JMTO)
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
The Japan-Multinational Trial Organization
Address
2-14-10 Marunouchi Naka-ku Nagoya City, Aichi, Japan
Tel
052-218-3301
jmto-adm@jmto.org
Secondary IDs
Secondary IDs
YES
Study ID_1
JMTO LC14-01
Org. issuing International ID_1
The Japan-Multinational Trial Organization (JMTO)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JMTO所属医療機関
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 26 | 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
81
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
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
DOI: 10.1002/cam4.5652
Standard versus low-dose nab-paclitaxel in previously treated patients with advanced non-small cell lung cancer: A randomized phase II trial (JMTO LC14-01)
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019656
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