UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013390
Receipt number R000015272
Scientific Title Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
Date of disclosure of the study information 2014/03/11
Last modified on 2016/09/11 11:42:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.

Acronym

Phase II study of weekly nab-PTX in patients with NSCLC previously treated with platinum-based chemotherapy.

Scientific Title

Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.

Scientific Title:Acronym

Phase II study of weekly nab-PTX in patients with NSCLC 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 efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Overall Survival
Progression Free Survival
Time to Treatment Failure
Disease Control Rate
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 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4weeks.

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-small cell lung cancer
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3) Disease progression or recurrence after the last treatment for non-small cell lung cancer is confirmed by radiological image. The number of previous regimens must be 2 or less
*Previous treatments should include at least one platinum-based regimen
*Adjuvant chemotherapy is counted as one regimen if the disease recurred within a year after the completion of postoperative adjuvant chemotherapy, or within a year after surgery in patients given preoperative adjuvant chemotherapy
* The following treatments are not counted as one regimen
1.Picibanil use for pleurosclerosis
2.Continuation maintenance therapy
3.EGFR-TKI and ALK inhibitor use for each driver mutation
4) At least one measurable lesion
5) Age of 20 years or older
6) ECOG Performance status of 0-2
7) Sufficient major organ function as bellow
*Neutrophil count >= 1,500 /mm3
*Platelet count >= 100,000 /mm3
*Hemoglobin >= 9.0 g/dL
*AST <= 100 IU/L
*ALT <= 100 IU/L
*total bilirubin <= 1.5 mg/dL
*PaO2 >= 60 Torr or more (or SpO2 >= 94% or more)
8) Written informed consent

Key exclusion criteria

(1) Previous treatment with paclitaxel
(2) Patients who remain influence of prior treatment which disturb protocol treatment
(3) Symptomatic brain metastasis
4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
5) Active infection requiring administration of systemic treatment with antibiotics. e.g. Body temperature rose higher than 38 degree centigrade
6) Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed
interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade 3 or higher angina
7) Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids
8) Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer
9) Confirmed or possible pregnancy, lactation, willingness to become pregnant
(for women), or willingness to have a child (for men)
10) Psychiatric disorder or symptom that makes participation of the patient difficult
11) Continuous administration of a steroid
12) Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuka Fujita

Organization

National Hospital Organization Asahikawa Medical center

Division name

Respiratory Medicine

Zip code


Address

7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan

TEL

0166-51-3161

Email

yuka@asahikawamc.hosp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuka Fujita

Organization

National Hospital Organization Asahikawa Medical center

Division name

Respiratory Medicine

Zip code


Address

7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan

TEL

0166-51-3161

Homepage URL


Email

yuka@asahikawamc.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Asahikawa Medical center

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


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

独立行政法人国立病院機構 旭川医療センター(北海道)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 11 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

Terminated

Date of protocol fixation

2013 Year 12 Month 13 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 11 Day

Last modified on

2016 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name