NCT03384238 Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
| NCT ID | NCT03384238 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | George Poultsides |
| Condition | Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2018-02-07 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2018-02-07 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
✉ gitrialeligibility@stanford.edu📞 (650) 498-7757
George Poultsides
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT03384238 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03384238 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03384238 currently recruiting?
Yes, NCT03384238 is actively recruiting participants. Contact the research team at gitrialeligibility@stanford.edu for enrollment information.
Where is the NCT03384238 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT03384238 clinical trial?
NCT03384238 is sponsored by George Poultsides. The principal investigator is George Poultsides at Stanford University. The trial plans to enroll 27 participants.