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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).
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).
Recruitment Status
Past Studies