Back to resultsPilot Study of 89-Zr Panitumumab in Pancreas Cancer
Primary Purpose
Pancreas Cancer
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
89Zr-panitumumab
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreas Cancer
Eligibility 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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
89Zr-Panitumumab
Arm Description
Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833959
Brief Title
Pilot Study of 89-Zr Panitumumab in Pancreas Cancer
Official Title
Pilot Study of 89Zr Panitumumab in Pancreas Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Business Decision
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
89Zr-Panitumumab
Arm Type
Experimental
Arm Description
Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection.
Intervention Type
Drug
Intervention Name(s)
89Zr-panitumumab
Intervention Description
Imaging Agent
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events assessed by CTCAE v5
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Iagaru
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of 89-Zr Panitumumab in Pancreas Cancer
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