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Pilot Study of 89-Zr Panitumumab in Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04833959
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Drug: 89Zr-panitumumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of 89Zr Panitumumab in Pancreas Cancer
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arm Intervention/treatment
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.
Drug: 89Zr-panitumumab
Imaging Agent




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833959


Contacts
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Contact: Alexander A Valencia 650-498-5185 alxndr@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Alexander A Valencia    650-498-5185    alxndr@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sub-Investigator: George A Fisher         
Sub-Investigator: George Poultsides         
Sub-Investigator: Eben Rosenthal         
Sub-Investigator: Carina Aparici         
Sub-Investigator: Guido Davidzon         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Andrei Iagaru Stanford Universiy
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04833959    
Other Study ID Numbers: IRB-57641
PANC0037 ( Other Identifier: OnCore )
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents