Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

A Phase 0, Open Label Study to Evaluate the Biodistribution and Pharmacokinetics of a Single Intravenous Bolus Dose of PTP-01 in Subjects With Resectable Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01962909
• Other study ID #: 16678
• Status: Terminated
• Phase: Phase 0
• First received: June 19, 2013
• Last updated: March 16, 2016
• Start date: November 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)

• subject must have adequate renal function

• ECOG performance status of 0-2

• women of child-bearing age and men must agree to use contraception prior to and during the study

Exclusion Criteria:

• subjects receiving any other investigational agents

• significant history of uncontrolled cardiac disease or central nervous system (CNS) disease

• pregnant or breastfeeding women

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• PTP-01
Dose level 1 is 10mCi (50ug of peptide)

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of PTP-01 to detect pancreatic ductal adenocarcinoma	requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01	up to 72 hours post dose	No
Secondary	Biodistribution and Binding Characteristics of PTP-01	Assessments will be made from imaging (whole body planar and SPECT/CT) and blood draws following PTP-01 dose. Tissue samples will also be retained for pathology.	up to 7 days post dose	Yes
Secondary	Clearance of PTP-01	Blood and urine samples will be collected to measure the level of radioactivity at specified intervals following PTP-01 dose.	up to 7 days post dose	Yes
Secondary	Safety and Tolerability of PTP-01	Clincial labs, ECGs, vital signs and physical exams will be performed up to 7 days post dose. Adverse events will be collected up to 30 days post dose.	up to 30 days post dose	Yes