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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009409
Receipt No. R000010816
Scientific Title A phase I/II study of Erlotinib plus WT1-W10 peptide vaccine for previously treated Non Small Cell Lung Cancer
Date of disclosure of the study information 2012/11/28
Last modified on 2014/04/01

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Basic information
Public title A phase I/II study of Erlotinib plus WT1-W10 peptide vaccine for previously treated Non Small Cell Lung Cancer
Acronym A phase I/II study of Erlotinib plus WT1 vaccine for previously treated NSCLC
Scientific Title A phase I/II study of Erlotinib plus WT1-W10 peptide vaccine for previously treated Non Small Cell Lung Cancer
Scientific Title:Acronym A phase I/II study of Erlotinib plus WT1 vaccine for previously treated NSCLC
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Objective of the study is to investigate efficacy and safety of Erlotinib plus WT1-W10 peptide vaccine for previously treated non- small cell lung cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: recommended dose, evaluation of safety
Phase II: response rate
Key secondary outcomes Phase II: disease control rate, progression free survival, overall survival, evaluation of safety and specific immune response

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 Vaccine
Interventions/Control_1 a combined chemoimmunotherapy of Erlotinib plus WT1-W10 peptide vaccine
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) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
2) Stage IIIB/IV (UICC-7) or postoperative recurrent NSCLC
3) Patients who have previously treated with one or two chemotherapy regimen(s). Postoperative oral UFT therapy does not mean previous chemotherapy regimen.
4) Patients who have not previously been treated with EGFR-TKI and / or WT1-W10 vaccine
5) Patients who have wild type EGFR gene or unknown status
6) Patients who have one of the following HLA types: A*24:02, A*02:01, A*02:06, A*02:07
7) Tumor tissues express WT1 antigen (if tissues are available)
8) Patients who has at least one or more measurable lesion(s) by RECIST.
9) Performance status (ECOG) 0-2
10) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management.
11) Patients aged 20 years or older.
12) Sufficient function of main organ and bone marrow filling the following criteria:
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
AST and ALT, x 2 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5 mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
SpO2 90% or above (while breathing ambient air).
13) Patients who are considered to survive for more than 3 months.
14) Patients providing written informed consent
Key exclusion criteria 1) Patients with active lung disease such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis, and considered as inappropriate for the study by the physicians
2) Patients with active severe infections
3) Impossible cases with oral administration
4) Patients with active severe opthalmological disease
5) Pregnancy or lactation
6) Patients with symptomatic brain metastasis
7) Patients with active concomitant malignancy
8) Patients with uncontrollable complications (e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea)
9) Inappropriate patients for this study judged by the physicians
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Yokoyama
Organization Kochi University, School of Medicine
Division name Department of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan
TEL 088-880-2345
Email im62@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kubota
Organization Kochi University, School of Medicine
Division name Department of Hematology and Respiratory Medicine
Zip code
Address Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan
TEL 088-880-2345
Homepage URL
Email im62@kochi-u.ac.jp

Sponsor
Institute Kochi University, School of Medicine, Department of
Hematology and Resporatory Medicine
Institute
Department

Funding Source
Organization NEC Corporation
Organization
Division
Category of Funding Organization Profit organization
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 高知大学医学部附属病院(高知)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 28 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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2015 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 27 Day
Last modified on
2014 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010816

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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