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Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac® in Subjects with Locally Advanced Pancreatic Adenocarcinoma

Primary: 1.Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to 3 (three) months after NanoPac® injection ] Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. Secondary: 1.Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® [ Time Frame: Up to 3 (three) months after NanoPac® injection ] Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection 2.Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® [ Time Frame: Up to 3 (three) months after NanoPac® injection ] Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection 3.Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® [ Time Frame: Up to 3 (three) months after NanoPac® injection ] Pharmacokinetic (PK) samples will be taken on Day 1 prior to injection, and at 1, 2, 4, 6, and 24 hours post-injection, and again at all study visits post-injection 4.Tumor Response (RECIST) [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ] Tumor burden at 3 months after NanoPac® injection will be compared with baseline tumor burden. 5.Change in pain score [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ] Pain scores will be measured using a visual analog scale 6.Change in tumor markers [ Time Frame: Baseline and 3 (three) months after NanoPac® injection ] Tumor markers measured will include CEA and CA19-9

Phase

IIa

Recruitment Status

Current Studies