Clinical Trial Details

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

Overview

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

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
NanOlogy, LLC
Duration
8 Months
Facility Type
N/A
Compensation

Eligibility

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
323-442-8107
ana.ortiz@health.usc.edu

Jacques Van Dam, MD, PhD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine
Nichole Stewart
713-798-0960
nlstewar@bcm.edu

Mohamed O Othman, MD
Principal Investigator

Contact

Shelagh Verco, PhD
805-595-1300
E-mail:

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