UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015841
Receipt number R000018432
Scientific Title Phase II Study of nab-paclitaxel in Treated Patients with Advanced Non-Small Cell Lung Cancer
Date of disclosure of the study information 2014/12/04
Last modified on 2020/12/13 18:03:41

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Basic information

Public title

Phase II Study of nab-paclitaxel in Treated Patients with Advanced Non-Small Cell Lung Cancer

Acronym

Phase II Study of nab-paclitaxel in Pretreated Patients with NSCLC

Scientific Title

Phase II Study of nab-paclitaxel in Treated Patients with Advanced Non-Small Cell Lung Cancer

Scientific Title:Acronym

Phase II Study of nab-paclitaxel in Pretreated Patients with NSCLC

Region

Japan


Condition

Condition

Treated patients with advanced non-small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of nab-paclitaxel in treated patients with advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

RR: response rate

Key secondary outcomes

PFS: progression free survival
OS: overall survival
DCR: disease control rate
Toxicity


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) day1,8,15 q3weeks

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-sqamous non-small-cell lung cancer with chemotherapy treated patients
2) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease
4) ECOG performance status 0-2
5) Adequate organ function
6) Excepted to live over 3 months after administration day
7) Written informed consent from the patients

Key exclusion criteria

1) Interstitial pneumonia/lung fibrosis on chest CT.
2) Previous drug allergy
3) History of poorly controlled pleural effusion, pericardial effusion and ascites.
4) Active infection.
5) Current Diarrhea.
6) Ileus or intestinal tract paralysis.
7) Symptomatic brain metastasis.
8) Active concomitant malignancy.
9) History of sever heart disease.
10) History of sever psychological disease.
11) Those judged to be not suitable by the attending physician.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tomoya
Middle name
Last name Kawaguchi

Organization

Graduate School of Medicine, Osaka City University

Division name

Department of Respiratory Medicine

Zip code

545-8586

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

0666453793

Email

i-gakumu@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Naruo
Middle name
Last name Naruo

Organization

Tohoku Medical and Pharmaceutical University

Division name

Department of pulmonology

Zip code

545-8586

Address

1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN

TEL

022-259-1221

Homepage URL


Email

y-naruo@sc4.so-net.ne.jp


Sponsor or person

Institute

Tohoku Medical and Pharmaceutical University

Institute

Department

Personal name



Funding Source

Organization

None

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

Graduate School of Medicine, Osaka City University

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

Tel

0666453793

Email

i-gakumu@med.osaka-cu.ac.jp


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

大阪市立大学医学部附属病院(大阪府)、大阪市立総合医療センター(大阪府)、石切生喜病院(大阪府)、淀川キリスト教病院(大阪府)、ベルランド病院(大阪府)、JR大阪鉄道病院(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 04 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

No longer recruiting

Date of protocol fixation

2014 Year 10 Month 31 Day

Date of IRB

2014 Year 11 Month 10 Day

Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2017 Year 01 Month 01 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 12 Month 03 Day

Last modified on

2020 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018432


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name