Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Part of paid clinical trials in Palo Alto, California.

Sponsor
George Poultsides
Study ID
NCT03384238
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorescence Imaging — PROCEDURE
    Undergo fluorescence imaging
  • Panitumumab — BIOLOGICAL
    Given IV
  • Panitumumab-IRDye800 — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Feb 7, 2018
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University, School of MedicinePalo AltoCalifornia94304
George Poultsides (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Stanford University, School of Medicine· Palo Alto, CA

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