UMIN-CTR Clinical Trial

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

Pancreatic cancer refractory to standard therapy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall Survival (OS)

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

OncoTherapy Science, Inc.

Institute

Department

Personal name

Organization

OncoTherapy Science, Inc.

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

2012

Year

02

Month

14

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2012

Year

02

Month

13

Day

Last modified on

2014

Year

12

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008586