Your session is about to expire
← Back to Search
Monoclonal Antibodies
Ficlatuzumab for Head and Neck Carcinoma
Phase 2
Waitlist Available
Led By Julie E. Bauman, MD, MPH
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at how well two different drugs work in treating patients with head and neck cancer that has come back or spread and is resistant to one of the drugs.
Eligible Conditions
- Head and Neck Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Oropharyngeal Carcinoma
- Squamous Cell Carcinoma
- Nasopharyngeal Carcinoma
- Lip and Oral Cavity Squamous Cell Carcinoma
- Head and Neck Cancers
- Oropharyngeal Cancer
- Lip and Oral Cavity Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Percentage of Participants With Dose Limiting Toxicities or Adverse Events
Other outcome measures
Change in Quality of Life
Genomic Biomarker Analysis
Immune Biomarker Analysis
+2 moreSide effects data
From 2022 Phase 2 trial • 78 Patients • NCT0342253665%
Hypoalbumenia
38%
Edema limbs
19%
Facial Edema
12%
Rash: Maculopapular
12%
Oral infection
8%
Pneumonitis
8%
Hyponatremia
8%
Anemia
8%
Hypotension
8%
Fatigue
8%
Rash: acneiform
8%
Dyspnea
8%
Pleural effusion
8%
Thromboembolic event
4%
Diarrhea
4%
Encephalopathy
4%
Facial edema
4%
Limb edema
4%
Pharyngeal Hemorrhage
4%
Dysphagia
4%
Headache
4%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Ficlatuzumab)
Arm II (Ficlatuzumab, Cetuximab)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (ficlatuzumab, cetuximab)Experimental Treatment2 Interventions
Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (ficlatuzumab)Experimental Treatment1 Intervention
Patients receive ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Ficlatuzumab
2015
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,075 Total Patients Enrolled
28 Trials studying Head and Neck Carcinoma
12,783 Patients Enrolled for Head and Neck Carcinoma
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,193 Total Patients Enrolled
2 Trials studying Head and Neck Carcinoma
20 Patients Enrolled for Head and Neck Carcinoma
Julie E. Bauman, MD, MPHPrincipal InvestigatorThe University of Arizona
1 Previous Clinical Trials
6 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger