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Nelfinavir (Viracept®) 1250 mg for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Led By Alexander Lin, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
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 5 years
Awards & highlights

Study Summary

This trial will test a new cancer treatment that combines chemotherapy, radiation, and a protease inhibitor.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Locoregional Control
Secondary outcome measures
Change in Glucose Metabolism From Nelfinavir
Decrease in Hypoxia From Nelfinavir

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT02207439
100%
White blood cell decreased
88%
Dysgeusia
82%
Dermatitis radiation
65%
Dysphagia
65%
Fatigue
59%
Salivary duct inflammation
53%
Anorexia
53%
Mucositis oral
47%
Anemia
47%
Constipation
47%
Diarrhea
47%
Dry mouth
41%
Nausea
41%
Neck edema
35%
Voice alteration
29%
Lymphocyte count decreased
29%
Hyponatremia
29%
Pain
24%
Erythema multiforme
24%
Weight loss
24%
Hypocalcemia
24%
Hypomagnesemia
24%
Cough
18%
Alanine aminotransferase increased
18%
Alopecia
18%
Anxiety
18%
Dizziness
18%
Neck pain
18%
Oral pain
18%
Tinnitus
18%
Tremor
12%
Investigations
12%
Vomiting
12%
Dyspnea
12%
Infections and infestations
12%
Hypokalemia
12%
Headache
12%
Fever
12%
Aspiration
12%
Edema limbs
12%
Hoarseness
12%
Alkaline phosphatase increased
12%
Creatinine increased
12%
Dehydration
12%
Depression
12%
Platelet count decreased
6%
Laryngeal edema
6%
Hyperglycemia
6%
Esophageal pain
6%
Gastroesophageal reflux disease
6%
Localized edema
6%
Sinus bradycardia
6%
Agitation
6%
Hyperkalemia
6%
Hypoalbuminemia
6%
Allergic reaction
6%
Aspartate aminotransferase increased
6%
Back pain
6%
Bullous dermatitis
6%
Gastroparesis
6%
Hemorrhoids
6%
Hiccups
6%
Hypotension
6%
Lymphocyte count increased
6%
Middle ear inflammation
6%
Cholecystitis
6%
Esophagitis
6%
Hypertension
6%
Neutrophil count decreased
6%
Ear pain
6%
Edema face
6%
Prostatic pain
6%
Rash maculo-papular
6%
Somnolence
6%
Sore throat
6%
Stomach pain
6%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm Phase 2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm Phase 2Experimental Treatment2 Interventions
Single Arm, Phase II study of Nelfinavir Lead-In (Period 1) Followed by Concurrent Chemoradiation with Nelfinavir (Period 2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelfinavir
FDA approved

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,077 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,677 Total Patients Enrolled
Alexander Lin, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
3 Previous Clinical Trials
212 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
2014. "Phase II Trial of Nelfinavir With Concurrent Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02207439.
~2 spots leftby Apr 2025
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