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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007279
Receipt No. R000008586
Scientific Title A randomized, double-blind, placebo-controlled phase3 clinical trial of OCV-C01 for patients with pancreatic cancer refractory to standard therapy
Date of disclosure of the study information 2012/02/14
Last modified on 2014/12/05

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Basic information
Public title A randomized, double-blind, placebo-controlled phase3 clinical trial of OCV-C01 for patients with pancreatic cancer refractory to standard therapy
Acronym COMPETE-PC Study
(COMbined PEptide ThErapy for Pancreatic Cancer)
Scientific Title A randomized, double-blind, placebo-controlled phase3 clinical trial of OCV-C01 for patients with pancreatic cancer refractory to standard therapy
Scientific Title:Acronym COMPETE-PC Study
(COMbined PEptide ThErapy for Pancreatic Cancer)
Region
Japan

Condition
Condition Pancreatic cancer refractory to standard therapy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of OCV-C01 with placebo control, comparing the overall survival for patients with pancreatic cancer refractory to standard therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall Survival (OS)
Key secondary outcomes

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 OCV-C01 1mL will be administered once a week as 1 treatment course for every 4 weeks, until patient's condition meets withdrawal criteria.
Interventions/Control_2 Placebo 1mL will be administered once a week as 1 treatment course for every 4 weeks, 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
80 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 at least one time.
-It doesn't matter weather patient had treated by another antitumor drug or radiation therapy.
(3) Patients must be >=20 years old and <=80 years old at the time of consent.
(4) Karnofsky Performance Status must be >=80.
(5) Patients must have Human Leukocyte Antigen (HLA)-A*24:02.
(6) Life Expectancy must be >=3 months.
(7) The following criteria must be satisfied in laboratory tests conducted within 21 days before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untried within 21days before laboratory tests.
-White blood cell count >=2,000/mm3 ,<=12,000/mm3
-Neutrophil count >=1,500/mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=75,000mm3
-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
(8) 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
(9) Patient must have signed the consent form
Key exclusion criteria (1) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2.
(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) Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding.
(5) Interstitial pneumonia or pulmonary fibrosis.
(6) Cerebral metastasis or being suspected.
(7) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(8) Serious infections or being suspected.
(9) Severe nervous disorder or mental disorder.
(10) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease.
(11) Complication of Grade 4 or another uncontrolled complication.
(12) History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01
(13) Unhealed traumatic lesion, including traumatic fracture
(14) Evidence of bleeding diathesis or severe coagulopathy, or patients with those histories
(15) Need continuous medication of antiplatelet drug except aspirin.
(16) Uncontrolled hypertension.
(17) Heart failure that needs treatment.
(18) Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
3.G-CSF
4.Erythropoietin
(19) Current participation in other clinical trials.
(20) 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 (during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.).
(21) The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Sakai
Organization OncoTherapy Science, Inc.
Division name Clinical Development Dept., Research & Development Division
Zip code
Address Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
TEL 044-820-8251
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization OncoTherapy Science, Inc.
Division name Clinical Development Dept., Research & Development Division
Zip code
Address Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
TEL 044-820-8251
Homepage URL
Email

Sponsor
Institute OncoTherapy Science, Inc.
Institute
Department

Funding Source
Organization OncoTherapy Science, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2012 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Terminated
Date of protocol fixation
2012 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 13 Day
Last modified on
2014 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008586

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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