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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 3 June 2014
Main ID:  JPRN-UMIN000001664
Date of registration: 27/01/2009
Primary sponsor: OncoTherapy Science, Inc.
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)
Scientific title:
Date of first enrolment: 2009/01/01
Target sample size: 150
Recruitment status: Completed
URL:  http://www.umin.ac.jp/ctr/index.htm
Study type:  Interventional
Study design:  Parallel Randomized  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
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.

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.


Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Unresectable Advanced and Recurrent Pancreatic Cancer
Intervention(s)
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.
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.
Primary Outcome(s)
Overall Survival(OS)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
FUSO Pharmaceutical Industries, Ltd.
Secondary Sponsor(s)
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