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

UMIN ID: UMIN000001664

Registered date:27/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable Advanced and Recurrent Pancreatic Cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Overall Survival(OS)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: OncoTherapy Science, Inc.
• Source(s) of Monetary Support: FUSO Pharmaceutical Industries, Ltd.