UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000151
Receipt number R000000217
Scientific Title Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer
Date of disclosure of the study information 2005/09/09
Last modified on 2015/08/31 15:52:46

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Basic information

Public title

Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer

Acronym

Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer

Scientific Title

Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer

Scientific Title:Acronym

Phase II study of gefitinib in patients with EGFR mutation positive- advanced non-small cell lung cancer

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To determine the efficacy and safety of gefitinib monotherapy for NSCLC patients with specific EGFR mutation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

(Primary Endpoint)
Response rate

Key secondary outcomes

(Secondary Endpoint)
Overall survival, One year survival, Time to progression, disease control rate, safety


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

gefitinib 250mg/m2 /day orally

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) Inoperable stage III or stage IV NSCLC
2) Chemonaive or prior 1-2 regimens of chemotherapy
3) Availability of tissue sample for mutation analyses
4) At least one measurable lesion
5) Age 20 years or older
6) Performance status (PS) of 0 to 2
7) Adequate main organ functions
8) No prior treatment of gefitinib or erlotinib
9) Written informed consent

Key exclusion criteria

Intestinal pneumonia or lung fibrosis
2) History of severe drug allergic reaction
3) Severe infection and complication (cardio insufficiency or hemorrhage etc.)
4) Severe diarrhea
5) Bowel obstruction,ileus
6) Symptomatic brain metastasis
7) History of other malignancy
8) Pregnant women or women willing child-bearing
9) No regulatory condition because of psychological disease
10) Inadequate condition diagnosed by primary physician

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Tamura MD

Organization

Kinki University School of Medicine, Nara Hospital

Division name

Department of Medical Oncology

Zip code


Address

1248-1, Otoda, Ikoma, Nara, 630-0293, Japan

TEL

0743-77-0880

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address

Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

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



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=18283321

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

2004 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2005 Year 03 Month 01 Day

Last follow-up date

2008 Year 03 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 09 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name