UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006273
Receipt number R000007427
Scientific Title A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation
Date of disclosure of the study information 2011/09/02
Last modified on 2014/09/02 12:49:19

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Basic information

Public title

A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

Acronym

A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

Scientific Title

A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

Scientific Title:Acronym

A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

Region

Japan


Condition

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the maximum tolerated dose (MTD) of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Maximum tolerated dose (MTD) of pemetrexed and gefitinib

Key secondary outcomes

Anti tumor efficacy


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 1 gefitinib250mg/day and pemetrexed (300mg/m2)
Level 2 gefitinib250mg/day and pemetrexed (400mg/m2)
Level 3 gefitinib250mg/day and pemetrexed (500mg/m2)
If none of the 3 patients who had been originally allocated to a dosage level experienced
DLT, the dose of pemetrexed was increased to the next level. If one of the 3 patients experienced DLT at that level, 3 additional patients were enrolled for the further evaluation of toxicity. If two of 3 patients experienced DLT at that level, that dose was defined as the MTD.

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histology/cytology-proven non-small cell lung cancer, age of 70 years or over
2)NSCLC harboring mutations of EGFR
3)Stage IIIB, IV
4)Chemotherapy na&iuml;ve patients
5)Performance status(ECOG): 0-1
6)Adequate organ function
7)Written informed consent

Key exclusion criteria

1)Serious infections
2)Serious clinical problems
3)Interstitial pneumonia/lung fibrosis on chest CT
4)Active concomitant malignancy
5)Symptomatic brain metastasis
6)Massive pericardial, pleural effusion, ascites
7)Previous drug allergy
8)Those judged to be not suitable by the attending physician

Target sample size

11


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Ichiki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Email

ichiki@kyumed.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masao Ichiki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Homepage URL


Email

ichiki@kyumed.jp


Sponsor or person

Institute

National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine

Organization

Division

Category of Funding Organization

Other

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

2011 Year 09 Month 02 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

Completed

Date of protocol fixation

2010 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2015 Year 03 Month 30 Day

Date of closure to data entry

2015 Year 09 Month 02 Day

Date trial data considered complete


Date analysis concluded

2015 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 02 Day

Last modified on

2014 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007427


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name