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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012404
Receipt No. R000014495
Scientific Title Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment in patients with advanced non-small-cell lung cancer(OLCSG1303)
Date of disclosure of the study information 2013/11/27
Last modified on 2017/12/02

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Basic information
Public title Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer(OLCSG1303)
Acronym Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer (OLCSG1303)
Scientific Title Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer(OLCSG1303)
Scientific Title:Acronym Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment
in patients with advanced non-small-cell lung cancer (OLCSG1303)
Region
Japan

Condition
Condition 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 In phase 1 part, the feasibility of a weekly nab-PTX treatment are evaluated
and the recommended schedule are decided for advanced / recurrent non-small
cell lung cancer (NSCLC) as second- or third-line treatment (who had a
history of prior platinum-based chemotherapy).

In phase 2 part , the efficacy and safety are evaluated with the recommended
schedule in phase 1 part.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Objective Response Rate
Key secondary outcomes safety and tolerability profile, progression-free survival, overall 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 nab-PTX 100mg/m2 administration on day1, 8, 15, 22 intravenously q 4 weeks
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 Histologicaly or cytologicaly confirmed advanced non-small cell lung cancer.
Wild type EGFR gene mutation (Unknown EGFR gene mutation status is allowed
for squamous cell carcinoma).
ALK fusion gene is negative or unknown.
One or two prior regimens containing a platinum-based chemotherapy.
Eastern Cooperative Oncology Group performance status 0-2.
Patient has measurable lesion(s) according to the RECIST ver.1.1 criteria
Adequate organ functions
Key exclusion criteria a case who has a history of paclitaxel or nab-paclitaxel treatment.
a case with symptom(s) caused by brain metastasis or a case with meningeal
dissemination.
a case who has treated with thoracic radiotherapy within 4 weeks or
radiotherapy for other site(s) within 2 weeks
a case who has major concomitant disease as interstitial lung disease,
severe cardiac disease(unstable angina pectoris, history of myocardial
infarction, uncontrolled arrhythmia, severe diabetes mellitus, active
infection, HBV/ HCV hepatitis or liver cirrhosis )
a case who met contraindications on a nab-PTX package leaflet.
Target sample size 55

Research contact person
Name of lead principal investigator
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-cho matsuyama-shi ehime pref.
TEL 81899991111
Email nnogami@shikoku-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daijiro Harada
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 160 kou minamiumemoto-cho matsuyama-shi ehime pref.
TEL 81899991111
Homepage URL
Email daharada@shikoku-cc.go.jp

Sponsor
Institute Okayama Lung Cancer Study Group (OLCSG)
Institute
Department

Funding Source
Organization Okayama Lung Cancer Study Group (OLCSG)
Organization
Division
Category of Funding Organization Other
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 国立病院機構 四国がんセンター(愛媛県)、岡山大学病院(岡山県)、岡山赤十字病院(岡山県)、岩国医療センター(山口県)、神戸赤十字病院(兵庫県)、川崎病院(岡山県)、山口宇部医療センター(山口県)、中国中央病院(広島県)、岡山ろうさい病院(岡山県)、住友別子病院(愛媛県)、倉敷中央病院(岡山県)岡山医療センター(岡山県)、福山市民病院(広島県)、愛媛県立中央病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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 11 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 26 Day
Last follow-up date
2017 Year 07 Month 11 Day
Date of closure to data entry
2017 Year 07 Month 27 Day
Date trial data considered complete
2017 Year 07 Month 27 Day
Date analysis concluded
2017 Year 08 Month 29 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 26 Day
Last modified on
2017 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014495

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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