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NCT04833959 Clinical Trial

Pilot Study of 89-Zr Panitumumab in Pancreas Cancer

Pancreas Cancer Clinical Trial

Official title:
Pilot Study of 89Zr Panitumumab in Pancreas Cancer

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04833959
Other study ID # IRB-57641
Secondary ID PANC0037NCI-2021
Status Suspended
Phase Phase 1
First received
Last updated
Start date March 26, 2021
Est. completion date March 2024

Study information
Verified date July 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 14
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 89Zr-panitumumab
Imaging Agent

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment emergent adverse events assessed by CTCAE v5 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. 7 days
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