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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027179
Receipt No. R000031102
Scientific Title A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
Date of disclosure of the study information 2017/05/01
Last modified on 2018/05/01

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Basic information
Public title A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
Acronym A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
Scientific Title A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
Scientific Title:Acronym A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
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 the safety and efficacy of TLP0-001 in combination with S-1.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression free survival
Response rate
Adverse events
Rate of dose limiting toxicity (first six patients in active group)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Active group:
TLP0-001 1mL will be administered bi-weekly as 1 treatment course for every 6 weeks. Besides, S-1 80mg/m2 will be administered for 4 weeks followed by a 2-week rest. Administration will be continued until patient's condition meets withdrawal criteria.
Interventions/Control_2 Placebo group:
Placebo 1mL will be administered bi-weekly as 1 treatment course for every 6 weeks. Besides, S-1 80mg/m2 will be administered for 4 weeks followed by a 2-week rest. Administration will be continued until patient's condition meets withdrawal criteria.
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) Invasive pancreatic ductal carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma. Presence of measurable disease is not considered.
(2) Refractory to standard therapy.
-Patient must have treated by Gemcitabine and nab-paclitaxcel at least one time.
-It doesn't matter weather patient had treated by another antitumor drug except for pyrimidine fluoride drug or radiation therapy.
(3) Patients must be >=20 years old and <=79 years old at the time of primary consent.
(4) Karnofsky Performance Status must be >=80.
(5) Patients must have prescribed type of Human Leukocyte Antigen both class I and class II.
(6) Life Expectancy must be >=3 months.
(7) The following criteria must be satisfied in laboratory tests conducted before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untried within 7 days before laboratory tests.
-White blood cell count >=3,000/mm3 ,<=12,000/mm3
-Neutrophil count >=1,500/mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=10,000mm3
-Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
-AST <=150 IU/L
-ALT <=150 IU/L
-Serum Creatinine <=1.5 mg/dL
-Creatinine clearance >=50 mL/min
(8) Oral intake is possible.
(9) The period from the end of previous treatment to the beginning of this trial must be satisfied following criteria.
-antitumor drug : >=15days
-domestic unrecognized drug which has anti-tumor effect. : >=29days, antibody drug : >=57days
-radiotherapy : >=29days
- laparotomy: >=15days
- systemic treatment of corticosteroid: >=15days
(10) Patient must have signed the consent form
Key exclusion criteria (1) Prior treatment of pyrimidine fluoride drug.
(2) Prior treatment of Cancer immunotherapy.
(3) Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer.
(4) Interstitial pneumonia or pulmonary fibrosis.
(5) History of severe hypersensitivity to S-1 or its component.
(6) History of hypersensitivity to OK-432, penicillin G, Gentamicin or streptomycin.
(7) History of hypersensitivity to pig-derived or mouse derived component.
(8) History of severe allergies (asthmaticus, anaphylactic shock etc).
(9) Water diarrhea.
(10) Cerebral metastasis or being suspected.
(11) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(12) Serious infections or being suspected.
(13) Positive for serum anti-HBs Ag or HBV-DNA.
(14) Positive for HCV Ab, HTLV1 Ab, HIV Ab, syphilis spirochete or parvovirus.
(15) Severe nervous disorder or mental disorder.
(16) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease.
(17) Complication of CTCAE Grade 4 or another uncontrolled complication.
(18) Need continuous medication of flucytosine, phenytoin or warfarin.
(19) Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
3.Erythropoietin
(20) Autoimmune disease that needs treatment.
(21) Test products can not be prepared to carry out at least one course (three times) from the autologous blood obtained by the apheresis performed before the secondary consent.
(22) Current participation in other clinical trials.
(23) 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.
(24) The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size 185

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
Email trial2nd@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Katsuda
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama, Japan
TEL 073-441-0613
Homepage URL
Email katsuda@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Tella 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
Address
Tel
Email

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 05 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 14 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 28 Day
Last modified on
2018 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031102

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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