Pilot Study of 89-Zr Panitumumab in Pancreas Cancer

Overview

The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.

Full Title of Study: “Pilot Study of 89Zr Panitumumab in Pancreas Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2022

Interventions

  • Drug: 89Zr-panitumumab
    • Imaging Agent

Arms, Groups and Cohorts

  • Experimental: 89Zr-Panitumumab
    • Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection.

Clinical Trial Outcome Measures

Primary Measures

  • Safety of 89Zr-panitumumab as a molecular imaging agent
    • Time Frame: 7 days
    • Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type.

Participating in This Clinical Trial

Inclusion Criteria

  • Confirmed diagnosis of pancreatic cancer. Exclusion Criteria:

  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. – History of infusion reactions to monoclonal antibody therapies. – Pregnant or breastfeeding. – Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. – Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. – Severe renal disease or anuria. – Known hypersensitivity to deferoxamine or any of its components.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrei Iagaru, Principal Investigator, Stanford Universiy
  • Overall Contact(s)
    • Alexander A Valencia, 650-498-5185, alxndr@stanford.edu

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