UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II clinical trial to evaluate the efficacy and safety of DFP-17729 in patients with unresectable/recurrent/progressive pancreatic cancer
Acronym	Phase I/II clinical trial of DFP-17729
Scientific Title	Phase I/II clinical trial to evaluate the efficacy and safety of DFP-17729 in patients with unresectable/recurrent/progressive pancreatic cancer
Scientific Title:Acronym	Phase I/II clinical trial of DFP-17729
Region	Japan

Condition
Condition	Patients with unresectable/recurrent/progressive pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase 1 To confirm the tolerability of DFP-17729 Phase 2 To evaluate the efficacy and safety of DFP-17729, and determine whether or not to transfer to Phase III clinical trials
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase 1 DLT Phase 2 OS
Key secondary outcomes	Phase 1 Safety assessment Adverse event, Side effects Pharmacokinetic evaluation Effectiveness evaluation ORR,DCR,CEA,CA19-9 Phase 2 Effectiveness evaluation PFS,ORR,DCR, CEA,CA19-9 Safety assessment Adverse event, Side effects

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration period 28 days or more
Interventions/Control_2	DFP-17729
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	Patients with 1)Invasive pancreatic ductal carcinoma 2)Stage 3 or 4 3) Have evaluable lesions 4) Standard regimen over 1 regimen 5) Patients with bone marrow or liver or renal function 6)PS 0 or 1 7) Patients expected to survive for 3 months or more 8) Age umder 20 9) Capable of treatment with oral medicine 10)IC
Key exclusion criteria	Patient without 1) Obvious infection 2) Severe heart diseases 3) Severe complicatios 4) Brain metasitases 5) Severe digestive diseases 6) Severe thromboembolisms 7) Severe diarrhea 8) Severe psychosis 9) Double cancer 10) Pregnant woman/ Breastfeeding 11) Continuous systemic administration of steroids 12) Effects of pretreatment 13) Blood transfusion and blood component preparation 14) Patients judged to be inappropriate
Target sample size	39

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Furuse
Organization	Kanagawa Cancer Center
Division name	Kanagawa Cancer Center
Zip code	241-8515
Address	2-3-2Nakao, Asahiku,Yokohamasi,Kanagawa
TEL	045-520-2222
Email	junjifuruse@yahoo.co.jp

Public contact
Name of contact person	1st name Kenzo Middle name Last name Iizuka
Organization	Delta-Fly Pharma, Inc.
Division name	R and D
Zip code	103-0023
Address	3-11-5,Nihonbashihoncho,Chuo-ku,Tokyo
TEL	03-6231-1278
Homepage URL
Email	kiizuka1206@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	Kyorin University Hospital
Address	6-20-2 Shinkawa,Mitaka-shi,Tokyo
Tel	0422475511
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	杏林大学医学部付属病院（東京都）、神奈川県立がんセンター（神奈川県）、国立がん研究センター東病院（千葉県）、がん研究会有明病院（東京都）、栃木県立がんセンター（栃木県）、埼玉県立がんセンター（埼玉県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 30 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	Completed
Date of protocol fixation	2020 Year 07 Month 29 Day
Date of IRB	2020 Year 10 Month 06 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry	2022 Year 09 Month 30 Day
Date trial data considered complete	2022 Year 10 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information	Nothing

Management information
Registered date	2020 Year 10 Month 09 Day
Last modified on	2022 Year 10 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047506