NCT03384238RecruitingPhase 1/2
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 19 Dec 2017
- Start date
- 7 Feb 2018
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- George Poultsides
- Diseases
- Pancreatic cancer
- NCT number
- NCT03384238
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 27
- From 7 Feb 2018 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Other illness
- History of infusion reactions to panitumumab or other monoclonal antibody therapies
Lab values
- 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
Other
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University, School of Medicine Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.