UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000142
Receipt number R000000204
Scientific Title PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer
Date of disclosure of the study information 2005/09/08
Last modified on 2005/09/08 16:45:28

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Basic information

Public title

PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer

Acronym

PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer

Scientific Title

PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer

Scientific Title:Acronym

PhaseII stady of gefitinib and in patients with relapsed advanced non-small cell lung cancer

Region

Japan


Condition

Condition

relapsed advanced non-small cell lung cartinoma


Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Determine the response rate and safety in patients with advanced non-small cell lung cancer treated with gefitinib and meloxicam.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Response rate

Key secondary outcomes



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

Patients receive oral gefitinib 250mg and meloxicam 10mg once daily

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 confirmed non-small lung cancer
(2)With clinical organization object before treatment
(3)Failed 1 or 2 prior treatment regimen for advanced non-small cell lung cancer.
(4)Aged 20 and over.
(5)Eastern Cooperative Oncology Group(ECOG) performance status 0-2
(6)With measurable lesion
(7)Adequate hematologic, hepatic, and renal functions
(8)No prior gefitinib
(9)More than 30days since prior chronic nonsteroidal nanti-inflammatory drugs(NAISDs)
(10)No history of peptic ulcer disease within the past 6 months
(11)More than 2 weeks prior therapy
(12)Life expectancy over 3 months
(13)Provide written informed consent

Key exclusion criteria

(1)Uncontrolled infection, cardiac disease, hepatic disease, and so on
(2)Evidence of interstitial lung disease in chest x-p
(3)Active brain metastases
(4)Other active malignancy
(5)History of bone marrow transplantation
(6)History of peripheral blood stem cell transplantation
(7)Allergy to any drugs
(8)Pregnant or nursing women
(9)Patients don't have will of contraception
(10)Uncontrolled diabetes
(11)Other concurrent serious medical condition

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Asuka Tsuya

Organization

Kinki University School of Medicine

Division name

Department of Medical Oncology

Zip code


Address

377-2, Ohno-Higashi, Osakasayama city, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kinki University School of Medicine

Division name

Department of Medical Oncology

Zip code


Address


TEL

072-366-0221

Homepage URL


Email



Sponsor or person

Institute

Department of Medical Oncology Kinki University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Oncology Kinki University 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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 08 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

Date of protocol fixation

2003 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2004 Year 02 Month 01 Day

Last follow-up date

2007 Year 02 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

2005 Year 09 Month 08 Day

Last modified on

2005 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name