UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I investigator initiated clinical trial using a novel WT1 peptide vaccine for patients with metastatic pancreatic cancer
Title of the study (Brief title)	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	Hiroki Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera Wakayama, Japan
TEL	073-441-0613
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	Motoki Miyazawa
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	mo-0702@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 08 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033517