UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002880 |
|---|---|
| Receipt number | 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 | 2023/12/22 12:56:58 |
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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 | Kazuma |
| Middle name | |
| Last name | Kishi |
Organization
Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name
Department of Respiratory Medicine
Zip code
JAPAN
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL
03-3588-1111
kazumak@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Misasko |
| Middle name | |
| Last name | Yamazaki |
Organization
Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name
Clinical Trial Centre
Zip code
JAPAN
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL
03-3588-1111
Homepage URL
chiken.jim@toranomon.gr.jp
Sponsor or person
Institute
Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
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
Clinical Trial Centre
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
Tel
03-3588-1111
chiken.jim@toranomon.gr.jp
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 12 | Day |
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
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003516
