UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009409 |
|---|---|
| Receipt number | 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 14:09:15 |
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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
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
im62@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University, School of Medicine, Department of
Hematology and Resporatory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010816
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| Registered date | File name |
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