UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010963
Receipt number R000012832
Scientific Title Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.
Date of disclosure of the study information 2013/06/17
Last modified on 2017/06/17 11:01:56

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Basic information

Public title

Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.

Acronym

Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.

Scientific Title

Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.

Scientific Title:Acronym

Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.

Region

Japan


Condition

Condition

Squamous cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine MTD and RD of nab-paclitaxel plus Nedaplatin chemotherapy in patients with advanced squamous cell lung cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Finding a decomending dose

Key secondary outcomes

evaluation of safety and response rate


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

Level 0
nedaplatin : 100mg/m2(day1)+
nab-paclitaxel: 60mg/m2(day1,8,15)
q4weeks

Level 1
nedaplatin : 100mg/m2(day1)+
nab-paclitaxel: 80mg/m2(day1,8,15)
q4weeks

Level 2
nedaplatin : 100mg/m2(day1)+
nab-paclitaxel: 100mg/m2(day1,8,15)
q4weeks

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven squamous cell lung cancer.
2) Clinical stage IIIB, IV or recurrent disease after surgery.
3) No prior chemotherapy.
No adjuvant chemotherapy within 1 years.
4) Age: 20 to 74
5) ECOG performance status of 0 or 1.
6) With at least one or more measurable lesion by RECIST.
7) Adequate organ function.
8) Life expectancy more than 3 months.
9) Written informed consent.

Key exclusion criteria

1) Severe infection.
2) Severe complications.
3) Uncontrollable pleural or pericardial effusion or ascites.
4) Superior vena cava syndrome.
5) Simultaneous or metachronous double cancers.
6) Symptomatic brain metastases.
7) Prior radiotherapy for primary tumor.
8) Radiotherapy other than primary tumor within 2 weeks.
9) A history of serious drug allergy or severe allergic reaction with albumin.
10) Psycologic illness

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriyuki Masuda

Organization

Kitasato University School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan

TEL

042-778-8111

Email

igawa@kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Igawa

Organization

Kitasato University School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan

TEL

042-778-8111

Homepage URL


Email

igawa@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University School of Medicine
Department of Respiratory Medicine

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

北里大学病院


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 06 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2017 Year 04 Month 01 Day

Date analysis concluded

2017 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 14 Day

Last modified on

2017 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name