UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001664
Receipt No. R000002006
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)
Date of disclosure of the study information 2009/01/27
Last modified on 2014/12/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Unresectable Advanced and Recurrent Pancreatic Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Overall Survival(OS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute OncoTherapy Science, Inc.
Institute
Department

Funding Source
Organization FUSO Pharmaceutical Industries, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2009 Year 01 Month 27 Day
Last modified on
2014 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002006

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.