UMIN-CTR Clinical Trial

Public title

Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study)

Acronym

Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study)

Scientific Title

Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study)

Scientific Title:Acronym

Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study)

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 OTS102 in combination with Gemcitabine

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II,III

Primary outcomes

Overall Survival(OS)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Active Group;Experimental
OTS102 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: 2years after enrollment.

Interventions/Control_2

Placebo Group:
Placebo 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: 2years after enrollment.

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)Pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or squamous cell carcinoma
2)Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cencer). Having of measurable lesions must not be required. Presence/absence of measurable lesions is not considered, but patients must undergo diagnostic imaging test within 21 days before enrollment.
3)Patients must have Histocompatibilitry Locus Antigen(HLA)-A*2402
4)Patients must be >=20 years old and & <=80 years old at the time of obtaining informed 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 befor resigtration.
-White blood cell count >=3,500 /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 patients with having double cancer could be permitted, although the treatment must be conducted at least 1 year ago.
9)Laparotomy must be conducted at least 1 week before enrollment.
10)Voluntarily signed the written consent form.

Key exclusion criteria

1)Prior treatment of OTS102 or KDR169
2)Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 1 year)
3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding
4)Presence of metastasis in central nervous system requiring therapy or with symptoms.
5)Presence of pleural effusion, ascites fluid, pericardial fluid requiring dreiage.
6)Active infections (excluding hepatitis B and C)
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 possible.
11)Chronic and systemic treatment of steroid
12)Interstitial pneumonia or pulmonary fibrosis (to be confirmed by chest X-ray within 21 days before enrollment)
13)History of myocardial infarction within 6 months before registration.
14)Evidence of bleeding diathesis or severe coagulopthy, or patients with those histories.
15)Need continuous medication of anticoagulant drug except aspirin
16)Uncontrolled hypertenstion.
17)Severe arrhythmia or heart failure.
18)Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception or lactation during the study period
19)Current paticipation in other drug clinical trials. (excluding the study, which doesn't need intervention)
20)As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Masami Sakai

Organization

Research & Development Division

Division name

Clinical Development Dept.

Zip code

Address

Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref. 213-0012 Japan.

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Research & Development Division

Division name

Clinical Development Dept.

Zip code

Address

Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan

TEL

Homepage URL

Email

Institute

OncoTherapy Science, Inc.

Institute

Department

Personal name

Organization

FUSO Pharmaceutical Industries, 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

2009

Year

01

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://meetinglibrary.asco.org/content/105112-133

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

2008

Year

12

Month

16

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

01

Month

27

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=R000002006