NCT04511078 Phase II Panitumumab-IRDye800 in Head & Neck Cancer
| NCT ID | NCT04511078 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-04-02 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2021-04-02 with a primary completion date of 2030-12-31.
⚠ 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
The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.
Eligibility Criteria
Inclusion Criteria: 1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck 2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed. 3. Planned standard of care surgery with curative intent for squamous cell carcinoma 4. Male or female patients age ≥ 18 years 5. Have life expectancy of more than 12 weeks 6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1 7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin ≥ 9 gm/dL 2. Absolute Neutrophil Count ≥ 1500 3. White Blood Cell count \> 3000/mm3 4. Platelet count ≥ 100,000/mm3 5. Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: 1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800 2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF 3. History of infusion reactions to any monoclonal antibody therapies 4. Women who are pregnant or breast-feeding 5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) 6. Magnesium or potassium lower than the normal institutional values 7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents 8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis 9. TSH \> 13 micro International Units/mL
Contact & Investigator
Anthony Morlandt, DDS MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT04511078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. 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 NCT04511078 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04511078 currently recruiting?
Yes, NCT04511078 is actively recruiting participants. Contact the research team at destinytaylor@uabmc.edu for enrollment information.
Where is the NCT04511078 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT04511078 clinical trial?
NCT04511078 is sponsored by University of Alabama at Birmingham. The principal investigator is Anthony Morlandt, DDS MD at University of Alabama at Birmingham. The trial plans to enroll 25 participants.
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