Recruiting
Phase 1
Phase 2

Panitumumab-IRDye800

Sponsor:

George Poultsides

Code:

NCT03384238

Conditions

Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Fluorescence Imaging

Panitumumab

Panitumumab-IRDye800

Study Details

Brief summary:

This phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to see how well it works in finding cancer in patients with pancreatic cancer who are undergoing surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with pancreatic cancer.

Conditions

Pancreatic Adenocarcinoma

Study ID

NCT03384238

Start date

Feb 7, 2018

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
  • Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
  • Life expectancy of more than 12 weeks
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level =< 1
  • Hemoglobin >= 9 gm/dL
  • Platelet count >= 100,000/mm\^3
  • Magnesium > the lower limit of normal per institution normal lab values
  • Potassium > the lower limit of normal per institution normal lab values
  • Calcium > the lower limit of normal per institution normal lab values
  • Thyroid-stimulating hormone (TSH) < 13 micro international units/mL

Exclusion Criteria:

  • Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
  • History of infusion reactions to panitumumab or other monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Evidence of corrected QT (QTc) prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 460 ms in females)
  • Lab values that in the opinion of the physician would prevent surgical resection
  • Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Study Design

Enrollment

27 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1a

A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices

experimental: Cohort 1b

Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices

experimental: Cohort 1c

Cohort 1c will receive 75 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab.A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices

experimental: Cohort 1d

Cohort 1d will receive a 50 mg dose of Panitumumab IRDye800 and no test/loading dose. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices

experimental: Cohort 2- Dose Expansion

Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1

Interventions

Fluorescence Imaging

Undergo fluorescence imaging

Panitumumab

Given IV

Panitumumab-IRDye800

Given IV

Primary outcome measure

  • Tumor to background ratio (TBR) [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

(650) 498-7757gitrialeligibility@stanford.edu

Locations

Stanford University, School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

gitrialeligibility@stanford.edu

Principal Investigator:

George Poultsides

More Information

Sponsor

George Poultsides

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Poultsides on 2026-03-17.