Pancreas Cancer
Conditions
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.
Interventions
DRUG89Zr-panitumumab
Imaging Agent
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed