UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002811
Receipt No. R000003423
Scientific Title Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Date of disclosure of the study information 2009/12/01
Last modified on 2014/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Acronym Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Scientific Title Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Scientific Title:Acronym Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Region
Japan

Condition
Condition Chemotherapy-treated recurrent non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical relevance of erlotinib for patients with chemotherapy-treated recurrent non-small cell lung cancer according to EGFR mutation status, and to search biomarkers for predicting erlotinib effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate at week 8.
Key secondary outcomes Response rate, waterfall plot analysis, progression free survival time, overall survival time, safety, biomarker analysis, detection of EGFR mutation in blood sample

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 treatment
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 Patients with all of the following conditions;
1) Non-small cell lung cancer proven by histology and/or cytology
2) Recurrent non-small cell lung cancer already treated with 1 or 2 regimen, excluding post-operative adjuvant chemotherapy
3) Tissue sampling available for biomarker search/analysis
4) Age equal or older than 20-y at enrollment
5) No prior treatment with EGFR-TKIs
6) Able to be treated with PO medication
7) Measurable lesion by RECIST
8) PS of 0, 1 or 2
9) Able to be intensely monitored at least for 2 weeks
10) Adequate organ functions, evaluated within 2 weeks before enrollment, as;
a) WBC >= 3,000/mm3
b) Netrophile >= 1,500/mm3
c) Hb >= 9.0 g/dL
d) Plt >= 100,000/mm3
e) AST/ALT <= 100 IU/L
f) T. Bil <= 1.5 g/dL
g) Serum creatinine <= 1.5 mg/dL
h) SpO2 >= 90%
11) Life expectancy of more than 3 months
12) Interval from previous treatment, of following, at enrollment;
a) Equal or more than 3 weeks after completion of previous chemotherapy
b) Equal or more than 4 weeks after completion of thoracic irradiation
c) Equal or more than 1 week after completion of irradiation except for thoracic irradiation
d) Equal or more than 2 weeks after surgical intervention including pleurodesis and pleural drainage
13) Witten informed consent from the patient
Key exclusion criteria Patients with at least one of the following conditions are ineligible
1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage
2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
3) Patients with infection requiring iv administration of antibiotics and/or antifungal agents
4) Patients unable to be treated with PO drugs
5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis
6) Pregnancy, breast feeding and suspected pregnancy
7) Symptomatic brain metastasis
8) Active synchronous malignancies
9) Uncontrolled diabetes mellitus
10) Other clinically significant complications
11) Other conditions inadequate for this research
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takiguchi, Yuichi
Organization Graduate School of Medicine, Chiba University
Division name Department of Respirology/Division of Clinical Oncology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2577
Email takiguchi@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takiguchi, Yuichi
Organization Graduate School of Medicine, Chiba University
Division name Department of Respirology/Division of Clinical Oncology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2577
Homepage URL
Email takiguchi@faculty.chiba-u.jp

Sponsor
Institute Department of Respirology/Division of Clinical Oncology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Department of Respirology/Division of Clinical Oncology, Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Chiba Cancer Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 G21031
Org. issuing International ID_1 Clinical study review board at Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学(千葉県)、千葉県がんセンター(千葉県)、その他交渉中

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 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 Terminated
Date of protocol fixation
2009 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 29 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003423

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.