Clinical Trial Details

NCT ID: NCT03077685
Date Last Changed: October 18, 2017


Research Study Summary

A clinical research study of NanoPac® for the treatment of Locally Advanced Pancreatic Adenocarcinoma

Research Study Title

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


Open-label, dose-escalating, Phase IIa trial of NanoPac® to treat subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas via direct intratumoral injection.

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Recruitment Details

18 to 75 Years
Overall Status
Lead Sponsor
NanOlogy, LLC
8 Months
Facility Type


All ages 18 Years to 75 Years

Inclusion Criteria:

  • Signed informed consent;

  • Age 18 to 75 years;

  • Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; located in the tail or body of the pancreas with a diameter of at least 2 cm but no more than 4cm;

  • Subject not a candidate for surgery;

  • Completion of at least one standard of care IV chemotherapy course; hematologic recovery must be confirmed prior to study entry;

  • Performance Status (ECOG) 0-1 at study entry;

  • Life expectancy of at least 3 months;

  • Adequate marrow, liver, and renal function:

  • ANC ≥ 1.5 x 109/L

  • Hemoglobin ≥ 9.5 grams/dL

  • Platelets ≥ 75 x 109/L

  • Total bilirubin ≤ 1.5x institutional ULN

  • AST/ ALT ≤ 2.5x institutional ULN

  • Creatinine ≤ 1.5x institutional ULN

  • Effective contraception if the risk of conception exists.

Exclusion Criteria:

  • Prior radiation therapy for pancreatic cancer;

  • Thrombotic or embolic events;

  • Acute or subacute intestinal occlusion;

  • History of inflammatory bowel disease;

  • Known hypersensitivity to study drugs;

  • Known drug or alcohol abuse;

  • Pregnant or breastfeeding women;

  • Previous or concurrent history of non-pancreatic malignancy except for metastatic pancreatic disease or non-melanoma skin cancer.

Site Locations (2)

Country State City Zip Facility and Contact
United States California Los Angeles 90033 Keck School of Medicine, University of Southern California
Ana Ortiz

Jacques Van Dam, MD, PhD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine
Nichole Stewart

Mohamed O Othman, MD
Principal Investigator


Shelagh Verco, PhD

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