UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000017010
Receipt No. R000019727
Scientific Title Weekly nab-PTX in Combination with Gemcitabine in Patients with Non-Small-Cell Lung Cancer Previously Treated with Platinum based Chemotherapy
Date of disclosure of the study information 2015/04/01
Last modified on 2019/12/10 (Ver. 6)

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Basic information
Public title Weekly nab-PTX in Combination with Gemcitabine in Patients with Non-Small-Cell Lung Cancer
Previously Treated with Platinum based Chemotherapy
Acronym Weekly nab-PTX in Combination with Gemcitabine in Lung Cancer patient
Previously Treated with Platinum based Chemotherapy
Scientific Title Weekly nab-PTX in Combination with Gemcitabine in Patients with Non-Small-Cell Lung Cancer
Previously Treated with Platinum based Chemotherapy
Scientific Title:Acronym Weekly nab-PTX in Combination with Gemcitabine in Lung Cancer patient
Previously Treated with Platinum based Chemotherapy
Region
Japan

Condition
Condition Non-Small-Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of weekly nab-PTX in combination with gemcitabine for patients previously treated with 1 regimen platinum-doublet.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Response rate
Overall survival
Disease control rate
Rate of adverse events

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(100mg/ m2 day1,8)
Gemciabine (1000mg/ m2 day1, 8)
The treatment is repeated every three weeks until disease progression or severe toxicity.
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 proven non-small cell lung cancer
2)non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery,who have previously treated platinum doublet.
3)With measurable lesion(RECIST version 1.1)
4)at an interval of more than four weeks from previous treatment
5)If the patient underwent therapy, there should be the following interval between the therapy and the registration
i)Radiotherapy other than thoracic radiation ->1 week
ii)Palliative radiotherapy including pulmonary field ->2 months
iii)Surgery(except CV-port reservation) ->4 weeks
iv)Thoracic drainarge ->2 weeks
v)Open biopsy, treatment of injury ->2 weeks
vi)Aspiration biopsy, CV-port reservation ->1 week
6)Age-> 20
7)ECOG PS 0-1
8)Adequate organ function
9)Life expectancy more than 3 months
10)Written informed consent
Key exclusion criteria 1)interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)history of drug induced interstitial pneumonia
3)history of severe drug allergy
4)patients previously treated with paclitaxel, gembcitabine, nab-paclitaxel.
5)history of active infection or other serious disease condition
6)history of poorly controlled pleural effusion,pericardial effusion and ascites
7)history of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,heart failure, etc.)
8)uncontrollable diabetes mellitus
9)curative radiotherapy pretreated to the chest.
10)current neuropathy >Grade2
11)history of active double cancer
12)history of active psychological disease
13)history of pregnancy or lactation
14)any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MOTOKO TACHIHARA
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan
TEL 078-382-5660
Email mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MOTOKO TACHIHARA
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017, Japan
TEL 078-382-5660
Homepage URL
Email mt0318@med.kobe-u.ac.jp

Sponsor
Institute Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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 神戸大学医学部附属病院（兵庫県）
明石医療センター（兵庫県）
神戸市立医療センター西市民病院(兵庫県）
先端医療センター（兵庫県）
高槻病院（京都府）


Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 01 Day

Related information
URL releasing protocol https://www.dovepress.com/a-multi-center-phase-ii-trial-of-nab-paclitaxel-and-gemcitabine-in-pat-pee
Publication of results Published

Result
URL related to results and publications https://www.dovepress.com/a-multi-center-phase-ii-trial-of-nab-paclitaxel-and-gemcitabine-in-pat-pee
Number of participants that the trial has enrolled 28
Results 
The overall response rate was 17.9%. The disease control rate was 67.9%. The
median progression-free survival was 3.1 months.
Adverse events were generally tolerable except grade 3 interstitial pneumonia with in 4 patients.
Results date posted
2019 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The median age was 68 years, and 23 were male and 5 female. The histologic subtypes were: adenocarcinoma in 19 patients, and squamous cell carcinoma in 9 patients.
Seventeen patients had ECOG PS 1 and 11 patients had PS 0. 24 patients were second line and 4 patients were third line.
Participant flow 
written informed consent
entry
treatment
Adverse events 
Adverse events were generally tolerable except grade 3 interstitial pneumonia with in 4patients (14.3%).
Outcome measures 
Primary endpoint; PFS
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 03 Month 18 Day
Date of IRB
2015 Year 04 Month 01 Day
Anticipated trial start date
2015 Year 04 Month 16 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 01 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019727