Pilot Study of 89-Zr Panitumumab in Pancreas Cancer

Phase 1

Withdrawn

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
89Zr-Panitumumab	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.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events assessed by CTCAE v5	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.

Secondary Outcome Measures

Name	Time	Method

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