UMIN-CTR Clinical Trial

Public title

Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer

Acronym

Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer

Scientific Title

Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer

Scientific Title:Acronym

Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer

Region

Japan

Condition

Unresectable Advanced and Recurrent Pancreatic Cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of OCV-101 in combination with Gemcitabine

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Overall Survival (OS)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

OCV-101 1mL will be administered by subcutaneous injection on days, 1,8,15 and 22 of each 28-day treatment cycles.
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days, 1, 8 and 15.
Time frame: Maximum 1.5years after enrollment.

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

1)Invasive pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or squamous cell carcinoma
2)Unresectable pancreatic cancer which the UICC stage grouping is III or IV (including recurrent pancreatic cancer). Having of measurable lesions must not be required. The patient who has recurrent pancreatic cancer and had resection except palliative operation is excluded from this study, whether the persistency of local lesion.
3)Patients must have Histocompatibility Locus Antigen(HLA)-A*2402
4)Patients must be >=20 years old and <=80 years old at the time of consent.
5)ECOG Performance Status must be 0 or 1.
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 >=3,500 /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)Patients with no previous treatment (radiotherapy, chemotherapy, etc.) for pancreatic cancer, except resection.
Previous treatment with radiotherapy, chemotherapy, etc. to the double cancer could be permitted, although the treatment must be conducted more than a year ago.
9)If the patient had laparotomy, it must be conducted 2 weeks or more before enrollment.
10)Patient must have signed the consent form.

Key exclusion criteria

1)Prior treatment of OCV-101, OTS102 or KDR169
2)Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 1 year) except carcinoma in situ or intramucosal cancer
3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding
4)Cerebral metastasis is doubted.
5)Moderate or greater pleural effusion, ascites fluid, pericardial fluid (requiring drainage).
6)Severe infections or being suspected.
7)Severe liver disorder or renal disorder, equivalent to CTCAE grade3 or greater.
8)Severe nervous disorder or mental disorder.
9)Uncontrolled diabetes mellitus.
10)Intestinal tract paralysis or being suspected.
11)Need chronic and systemic treatment of steroid.
12)Interstitial pneumonia or pulmonary fibrosis.
13)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-101.
14)Unhealed traumatic lesion, including traumatic fracture.
15)Evidence of bleeding diathesis or severe coagulopathy, or patients with those histories.
16)Need continuous medication of ant platelet drug except aspirin.
17)Uncontrolled hypertension.
18)Arrhythmia or heart failure that needs treatment.
19)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.).
20)Current participation in other drug clinical trials. (excluding the study, which doesn't need intervention)
21)Other serious complication.
22)The subject who was determined by investigator that being not adequate to participate in the trial.

Target sample size

30

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

03

Month

04

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

01

Month

14

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

01

Day

Last follow-up date

2013

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

01

Day

Last modified on

2013

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006130