UMIN-CTR Clinical Trial

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

Pancreatic cancer refractory or intolerable to standard therapy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

OncoTherapy Science, Inc.

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Co.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

07

Month

29

Day

Last modified on

2012

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007189