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A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms

Primary Outcome Measures 1.Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to 6 (six) months after NanoPac® injection ] Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. Secondary Outcome Measures: 1.Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ] 2.Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ] 3.Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® [ Time Frame: Up to 6 (six) months after NanoPac® injection ] 4.Cyst volume response [ Time Frame: Screening and 6 (six) months after NanoPac® injection ] Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).

Phase

II

Recruitment Status

Past Studies