UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000017010
Receipt number	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 13:47:12

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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

Non-Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

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

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

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 or person

Institute

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

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019727

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name