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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006074
Receipt No. R000007189
Scientific Title Phase1 study of OCV-105 in patients with pancreatic cancer refractory or intolerable to standard therapy
Date of disclosure of the study information 2011/08/01
Last modified on 2012/06/11

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Basic information
Public title Phase1 study of OCV-105 in patients with pancreatic cancer refractory or intolerable to standard therapy
Acronym Phase1 study of OCV-105 in patients with pancreatic cancer refractory or intolerable to standard therapy
Scientific Title Phase1 study of OCV-105 in patients with pancreatic cancer refractory or intolerable to standard therapy
Scientific Title:Acronym Phase1 study of OCV-105 in patients with pancreatic cancer refractory or intolerable to standard therapy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety of OCV-105 by subcutaneous administration.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The incidence of adverse event and Dose-Limiting Toxicity (DLT).
Key secondary outcomes Tumor regression effect with RECIST 1.1.
Transition of Laboratory evidence and Vital signs.

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 [Course 1 (DLT evaluation period)]
OCV-105 3.0mg/ml will be administered on day1, 8, 15, and 22 by subcutaneous injection to the axilla or inguinal region.
[On and after Course 2]
OCV-105 3.0mg/ml will be administered once a week until patient's condition meets discontinuance criteria.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria.
(1)Invasive pancreatic ductal carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma.
(2)Refractory or intolerable 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.
-Recurrent case is:
Recurrence during adjuvant therapy (Gemcitabine) or recurrence within 28 days from the end of adjuvant therapy (treated for more than 3months [12 weeks]).
Recurrence after the adjuvant therapy (Gemcitabine) was completed, and turned refractory or intolerable to Gemcitabine.
(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 enrollment.
-White blood cell count >=3,000 /mm3 ,<=12,000/mm3
-Neutrophil count >=2,000 /mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=100,000 /mm3
-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 : >=2weeks
-radiotherapy : >=4weweks
-laparotomy : >=2weeks
-systemic treatment of corticosteroid : >=2weeks
(9)Patients who can accept to be hospitalized for the period provided by protocol.
(10)Patient must have signed the consent form.
Key exclusion criteria Exclusion criteria.
(1)Prior treatment of peptide derived from KIF20A, or peptide which is designed for antitumor effect.
(2)Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer.
(3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding.
(4)Interstitial pneumonia or pulmonary fibrosis.
(5)Cerebral metastasis or being suspected.
(6)Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(7)Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease.
(8)Another uncontrolled complication.
(9)Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
3.G-CSF
4.Erythropoietin
(10)Current participation in other clinical trials.
(11)Patient who receive treatment of drug which is not on sale in Japan (Investigational drug or private import drug) within 2 months before enrollment.
(12)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.).
(13)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 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
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 044-820-8259
Homepage URL
Email

Sponsor
Institute OncoTherapy Science, Inc.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co.,LTD.
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
2011 Year 08 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 Completed
Date of protocol fixation
2011 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2012 Year 08 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
2011 Year 07 Month 29 Day
Last modified on
2012 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007189

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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