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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033062
Receipt No. 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 2019/07/10

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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
Email 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
Email tsuzuki1206@delta-flypharma.co.jp

Sponsor
Institute Delta-Fly Pharma, Inc.
Institute
Department

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
Email 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 Enrolling by invitation
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 04 Month 30 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
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037700

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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