Pilot Study of 89-Zr Panitumumab in Pancreas Cancer

Sponsor

Stanford University (Other)

Overall Status

Suspended

CT.gov ID

NCT04833959

Collaborator

(none)

Enrollment

Location

Arm

35.2

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Drug: 89Zr-panitumumab	Phase 1

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 26, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Andrei Iagaru, Stanford Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT04833959

Other Study ID Numbers:

IRB-57641
PANC0037
NCI-2021-03447

First Posted:

Apr 6, 2021

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Panitumumab

Study Results

No Results Posted as of Jun 21, 2022