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Monoclonal Antibodies

Panitumumab-IRDye800 Imaging for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By George Poultsides

Research Sponsored by Eben Rosenthal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned standard of care surgery with curative intent for pancreatic adenocarcinoma

Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to find pancreatic cancer during surgery, by using a combination of the drug panitumumab and an investigational dye called IRDye800CW. The dye makes cancer cells more visible when seen through a special camera.

Who is the study for?

This trial is for individuals with suspected or confirmed pancreatic adenocarcinoma who are planning surgery to remove the cancer. They should have a life expectancy of over 12 weeks, be relatively active (able to care for themselves), and have normal blood counts and electrolyte levels. It's not suitable for those with certain health conditions that aren't listed here.

What is being tested?

The study is testing Panitumumab-IRDye800, which combines an antibody drug with a special dye visible using a camera during surgery. The goal is to see if this makes cancer cells easier to find and remove during operations in patients with pancreatic cancer.

What are the potential side effects?

Possible side effects include reactions related to panitumumab such as skin rash, fatigue, abdominal pain, nausea, and allergic reactions. The IRDye800CW may cause unknown side effects since it's investigational.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove pancreatic cancer.

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I have been diagnosed with pancreatic cancer.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor to background ratio (TBR)

Secondary study objectives

Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug

Number of positive lymph nodes per participant, not detected by white light

Number of positive resection margins per participant, not detected by white light

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 2- Dose ExpansionExperimental Treatment3 Interventions

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

Group II: Cohort 1dExperimental Treatment3 Interventions

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

Group III: Cohort 1cExperimental Treatment3 Interventions

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

Group IV: Cohort 1bExperimental Treatment3 Interventions

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

Group V: Cohort 1aExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorescence Imaging

2014

Completed Phase 2

~100

Panitumumab

2017

Completed Phase 3

~7150