UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033062 |
|---|---|
| Receipt number | R000037700 |
| Scientific Title | Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC. |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2022/06/07 14:02:27 |
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Basic information
Public title
Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.
Acronym
Phase II study of DFP-14323
Scientific Title
Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.
Scientific Title:Acronym
Phase II study of DFP-14323
Region
| Japan |
Condition
Condition
NSCLC
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease Control Rate(DCR)
Key secondary outcomes
Efficacy
1)Objective Response Rate
2)Nuetrophil/Lymphocyte Rate
3)Tumor Maker
Safety
Rate of AE and SE
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DFP-14323 Afatinib20mg 72weeks
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with
1) Histological NSCLC
2) Stage III/IV
3) exon19 del/ exon21 L858R
4) Measurable lesions
5) First line chemo
6) Normal major organ's function
7) PS0-2
8) Life Expectancy 3M
9) Age 20-84
10) Capable of treatment with oral medicine
11) ECG within 4w
12) IC
Key exclusion criteria
Patients without
1) Contraindicated cases for Erlotinib or Afatinib or Osimertinib
2) Obvious infections
3) T790M, exon20 ins
4) Severe heart diseases
5) Severe complications
6) Brain metasitases
7) Severe digestive diseases
8) Severe thromboembolisms
9) Severe diarrhea
10) Severe psychosis
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hiroshige |
| Middle name | |
| Last name | Yoshioka |
Organization
Kansai Medical University
Division name
Thoracic Oncology
Zip code
573-1191
Address
2-3-1,Shinmachi,Hirakata-Cty,Osaka
TEL
072-804-0101
hgyoshioka@gmail.com
Public contact
Name of contact person
| 1st name | Tsuneo |
| Middle name | |
| Last name | Suzuki |
Organization
Delta-Fly Pharma, Inc.
Division name
Domestic R&D
Zip code
108-0023
Address
3-11-5, Nihonbashihoncho, Chuo-ku, Tokyo
TEL
03-6231-1278
Homepage URL
tsuzuki1206@delta-flypharma.co.jp
Sponsor or person
Institute
Delta-Fly Pharma, Inc.
Institute
Department
Personal name
Funding Source
Organization
Delta-Fly Pharma, Inc.
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
Delta-Fly Pharma, Inc.
Address
3-11-5, Nihonbashihoncho, Chuo-ku, Tokyo
Tel
03-6231-1278
tsuzuki1206@delta-flypharma.co.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
北野病院（大阪府）他8施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
2018/9/29 addition of Osimertinib as concomitant
2018/11/6 IRB approved
2019/03/12 Observation 24w->72w Concomitant=Afatinib Only
Management information
Registered date
| 2018 | Year | 06 | Month | 20 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037700
