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New treatment option for Pancreatic Adenocarcinoma
Official title Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
ClinicalTrials.gov ID: NCT03384238
What this study is testing
What is Panitumumab?
Panitumumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic adenocarcinoma.
Also referred to as ABX-EGF, ABX-EGF Monoclonal Antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.