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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002880
Receipt No. R000003516
Scientific Title Prospective Phase ll trial of Erlotinib for Advanced Non Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations
Date of disclosure of the study information 2009/12/11
Last modified on 2014/06/12

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Basic information
Public title Prospective Phase ll trial of Erlotinib for Advanced Non Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations
Acronym Prospective Phase ll trial of Erlotinib for Advanced Non Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations
Scientific Title Prospective Phase ll trial of Erlotinib for Advanced Non Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations
Scientific Title:Acronym Prospective Phase ll trial of Erlotinib for Advanced Non Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations
Region
Japan

Condition
Condition Non-small cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate efficacy and safety of Erlotinib for previously treated Non-small cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate (RR)
Key secondary outcomes Progression-free survival (PFS)
Overall survival (OS)
Toxicity profiles
Quality of life

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 Erlotinib 150mg 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer.
2) Patients who have previously treated one platinum containing regimen (adjuvant chemotherapy counts one regimen).
3) Patients having EGFR mutation (exon 19 deletion or L858R)
4) Patient who has at least one or more measurable lesion by RECIST.
5) ECOG performance status (PS): 0-2
6) Patients who can be hospitalized for one or two weeks after beginning of the treatment or under management to apply to it.
7) Patients aged 20 years or older.
8) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
Leukocyte counts, 3,000/mm3 or over -12,000/mm or less.
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.0g/dL or over
AST and ALT, x 2 of upper limit of normal (ULN) or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
BUN, 25mg/dL or less
Adequate heart function by ECG
SpO2 90% or above.
9) Patients who are considered to survive for more than 3 months.
9) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.)
10)
(1)Chemotherapy: more than 4weeks after the last chemotherapy
(2)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs
(3)Operation: more than 4weeks after the last operation(including pleurodesis)
11) Written informed consent.
Key exclusion criteria 1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis
2)Patients with massive pleural or pericardial effusion ,or ascites
3)Patients with active severe infections
4)Cases with past history of administration of HER related agents
5)Impossible cases with oral administration
6)Patients with active opthalmological disease
7) Patients with active concomitant malignancy
8) Patients with symptomatic brain metastasis
9)Patients with double cancer
10)Patients with uncontrollabe diabetes mellitus
11)Patients with uncontrollable complications
12)Inappropriate patients for this study judged by the physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuma Kishi
Organization Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name Department of Respiratory Medicine
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL 03-3588-1111
Email kazumak@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misasko Yamazaki
Organization Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name Clinical Trial Centre
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL 03-3588-1111
Homepage URL
Email chiken.jim@toranomon.gr.jp

Sponsor
Institute Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Department of Respiratory Medicine
Institute
Department

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
2009 Year 12 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 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
2009 Year 12 Month 11 Day
Last modified on
2014 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003516

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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