UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042064 |
|---|---|
| Receipt number | R000047506 |
| Scientific Title | Phase I/II clinical trial to evaluate the efficacy and safety of DFP-17729 in patients with unresectable/recurrent/progressive pancreatic cancer |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2022/10/11 13:54:42 |
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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
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
kiizuka1206@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
Kyorin University Hospital
Address
6-20-2 Shinkawa,Mitaka-shi,Tokyo
Tel
0422475511
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047506
