UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029428 |
|---|---|
| Receipt number | R000033517 |
| Scientific Title | Phase I investigator initiated clinical trial using a novel WT1 peptide vaccine for patients with metastatic pancreatic cancer |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2018/04/07 07:10:13 |
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Basic information
Public title
Phase I investigator initiated clinical trial using a novel WT1 peptide vaccine for patients with metastatic pancreatic cancer
Acronym
Phase I clinical trial using WT1 peptide vaccine for patients with metastatic pancreatic cancer.
Scientific Title
Phase I investigator initiated clinical trial using a novel WT1 peptide vaccine for patients with metastatic pancreatic cancer
Scientific Title:Acronym
Phase I clinical trial using WT1 peptide vaccine for patients with metastatic pancreatic cancer.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate exploratory the safety and efficacy of WT1 peptide vaccine cocktail (DSP-7888).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence of DLT related to investigational drug.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(1) Investigational drug
DSP-7888 10.5mg will be administered intracutaneously weekly for 8 weeks (2 courses).
After 2 courses, DSP-7888 3.5mg will be administered intracutaneously bi-weekly.
(2) Combined drugs
Gemcitabine plus nab-PTX will be administered intravenously at day 1, day 8, day15 followed by one week rest as one course.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Metastatic pancreatic carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma (2) No prior chemotherapy and radiotherapy
(3) ECOG Performance Status must be 0 or 1.
(4) Patients must have following type of Human Leukocyte Antigen class I; HLA-A*24:02, HLA-A*02:01/06
(5) Life Expectancy must be >=3 months.
(6) Patients must be >=20 years old and <=79 years old at the time of consent.
(7) The following criteria must be satisfied in screening laboratory data.
-White blood cell count <=12,000/mm3
-Neutrophil count >=1,500/mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=10,000mm3
-Total bilirubin <=1.25 times ULN
-AST, ALT <=2.5 times ULN
-Serum Creatinine <=1.5 mg/dL
(8) Patient must have signed the consent form
Key exclusion criteria
(1) Interstitial pneumonia or pulmonary fibrosis
(2) Comfirmed or suspicious brain metastatis
(3) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(4) Severe infection or being suspected
(5) Positive for serum HBs Ag or HBV-DNA
(6) Positive for anti-HCV or anti-HIV ab
(7) Patients who require systemic administration of Corticosteroid
(8) Prior DSP-7888, other WT1 peptides, or WT1 immunotherapy
(9) History of severe allergies to oil products
(10) History of hypersensitivity to paclitaxel, albumin, and gemcitabine
(11) Active another cancer to define the pprognosis
(12) Severe mental disorders
(13) Peripheral neuropathy >=CTCAE ver.4.0JCOG Grade 2
(14) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease.
(15)Myocardial infarction, severe unstable angina pectoris, colonary or peripheral artery bypass, congestive heart failure, cerebrovascular disease, pulmonary embolization, deep vein thrombosis or other severe thromboembolism within 12 months
(16) Bleeding tendency or severe coagulation disorder
(17) Current participation in other clinical trials.
(18) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period.
(19) The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Miyazawa |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera Wakayama, Japan
TEL
073-441-0613
Homepage URL
mo-0702@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 10 | 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
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2018 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033517
