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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name