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Main
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Note: This record shows only 22 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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000001664 |
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Date of registration:
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27/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study)
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Scientific title:
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Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study) - Phase2/3 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer(PEGASUS-PC Study) |
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Date of first enrolment:
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2009/01/01 |
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Target sample size:
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150 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002006 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II,III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Research & Development Division Clinical Development Dept. |
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Name:
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Masami Sakai |
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Address:
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Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref. 213-0012 Japan.
Japan |
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Telephone:
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Email:
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Affiliation:
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Research & Development Division Clinical Development Dept. |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
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Health Condition(s) or Problem(s) studied
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Unresectable Advanced and Recurrent Pancreatic Cancer
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Intervention(s)
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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.
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Primary Outcome(s)
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Overall Survival(OS)
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Source(s) of Monetary Support
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FUSO Pharmaceutical Industries, Ltd.
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Ethics review
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Status: YES
Approval date:
Contact:
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