An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer
Sponsor: Ono Pharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-limiting toxicities（DLT）
Time frame: 28 days
Adverse event(AE)
Time frame: UP to 28 days after the last dose
Secondary Endpoints
Pharmacokinetics (Plasma concentration for ONO-4578)
Pharmacokinetics (Serum concentration for ONO-4538)
Overall response rate (ORR)
Eligibility Criteria
Inclusion Criteria: * 1\. Pancreatic invasive ducatal adenocarcinoma * 2\. Life expectancy of at least 3 months * 3\. Patients with ECOG performance status 0 or 1 Exclusion Criteria: * 1\. Patients with severe complication * 2\. Patients with multiple primary cancers
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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