UMIN-CTR Clinical Trial

Public title

Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer

Acronym

Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer

Scientific Title

Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer

Scientific Title:Acronym

Phase II study of nab-paclitaxel in patients with previously treated non-small cell lung cancer

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To explore efficacy and safety of nab-paclitaxel in patients with previously treated non-small cell lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate

Key secondary outcomes

Overall survival, Progression free survival, Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

nab-paclitaxel is administered at a dose of 100mg/m2 intravenously on day1,8,15.
A treatment cycle is repeated every 28 days.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed diagnosis on non-small cell lung cancer. Non-small cell lung cancer with stage IIIB, stage IV, recurrent disease.
2)The patients who previously treated with the chemotherapy of 1 or 2 regimen including the platinum combination chemotherapy.
Recurrence within 6 months or less from the adjuvant chemotherapy finished is considered a previous treatment.
Patients with active EGFR mutations or ALK translocations need previously treated with EGFR-TKIs, Crizotinib, respectively. (but not count as 1 regimen)
3)Without treatment history of nab - paclitaxel or paclitaxel
4)Interval from previous chemotherapy
EGFR-TKI, Crizotinib : more than 14 days
Other chemotherapy: more than 28 days
5)Interval from previous palliative radiotherapy and surgery (for metastatic site) : more than 14 days after the last treatment
6)Interval from previous chest radiotherapy: more than 42 days after the last irradiation to lung
7)The presence of measureable lesions by RECIST
8)Age of 20 years or older
9)Performance Status (ECOG) 0 - 2
10)Adequate organ function
Granulocyte count 1,500/mm3 or over
Platelet count 100,000/mm3 or over
Hb 9.0g/dL or over
AST/ALT 2.5 x the Upper Limits of Normal (ULN) or under
Total bilirubin 1.5mg/dL or under
Serum creatinine 1.0 x the Upper Limits of Normal (ULN) or under
SpO2 90 % or over
11)Life expectancy more than 3 months
12)Written informed consent to participate

Key exclusion criteria

1)Small cell carcinoma (in the whole or a part of the tumor)
2)Interstitial pneumonia or pulmonary fibrosis detectable on X ray
3)Uncontrolled pleural effusion, ascites, or pericardial effusion
4)Symptomatic brain metastasis
5)Active synchronous malignant neoplasm
6)Uncontrolled diabetes or hypertension
7)History of severe heart disease
8)Anamnesis of hypersensitivity to paclitaxel or albumin
9)Anamnesis of hypersensitivity to drugs
10)Patients with severe infection
11)Pregnancy or lactating patients
12)Patients who were judged inappropriate to entry this study by physician

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Asuka Tsuya

Organization

Osaka City General Hospital

Division name

Department of clinical oncology

Zip code

Address

2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka 534, Japan

TEL

06-6929-1221

Email

a-tsuya@med.osakacity-hp.or.jp

Name of contact person

1st name
Middle name
Last name	Asuka Tsuya

Organization

Osaka City General Hospital

Division name

Department of clinical oncology

Zip code

Address

2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka 534, Japan

TEL

06-6929-1221

Homepage URL

Email

a-tsuya@med.osakacity-hp.or.jp

Institute

Osaka City General Hospital

Institute

Department

Personal name

Organization

Osaka City General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

10

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

02

Month

28

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

23

Day

Last modified on

2017

Year

11

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014133