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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for surgery to remove pancreatic cancer.
Select...
I have been diagnosed with pancreatic cancer.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor to background ratio (TBR)
Secondary outcome measures
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
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
2020
Completed Phase 3
~6490
Panitumumab-IRDye800
2019
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Eben RosenthalLead Sponsor
8 Previous Clinical Trials
145 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,494 Total Patients Enrolled
George PoultsidesPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with pancreatic cancer.I am scheduled for surgery to remove pancreatic cancer.I can care for myself but may not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1a
- Group 2: Cohort 1b
- Group 3: Cohort 1c
- Group 4: Cohort 1d
- Group 5: Cohort 2- Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities to join this experiment?
"According to clinicaltrials.gov, this particular medical study is not presently searching for participants. It was initially listed on February 7th 2018 and has been amended as recently as June 21st 2022. This trial no longer requires volunteers; however, there are 820 other trials recruiting at the present moment."
Answered by AI
Is this groundbreaking trial the initial of its species?
"Currently, 33 live studies of Panitumumab-IRDye800 are happening across 141 cities and 15 countries. In 2011 Amgen sponsored a Phase 2 trial with 75 participants which marked the beginning of an ongoing research effort that has seen 103 such investigations in the past decade."
Answered by AI
What is the aggregate size of the population engaging in this research endeavor?
"This trial is not currently open for enrolment. It was originally posted on February 7th 2018 and had its last edit on June 21st 2022. If you are exploring additional clinical studies, there are currently 787 trials recruiting patients with adenocarcinoma and 33 looking to involve Panitumumab-IRDye800 in their protocol."
Answered by AI
What prior experiments have incorporated Panitumumab-IRDye800?
"Presently, 33 ongoing trials for Panitumumab-IRDye800 exist with 3 within Phase 3. Of these studies, multiple are in Nagoya-shi, Aichi and 561 sites worldwide host them."
Answered by AI
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